Docking stations for transcatheter valves

ABSTRACT

Docking stations for transcatheter valves are described. The docking stations can include an expandable frame, at least one sealing portion, and a valve seat. The expandable frame can be configured to conform to an interior shape of a portion of the circulatory system when expanded inside the circulatory system. The sealing portion can be configured to contact an interior surface of the circulatory system to create a seal. The valve seat can be connected to the expandable frame and can be configured to support an expandable transcatheter valve. The docking stations are adaptable to different anatomies/locations to allow implantation of a transcatheter valve in a variety of anatomies/locations.

CROSS-REFERENCE

The present application is a continuation of U.S. InternationalApplication No. PCT/US2018/040425 filed Jun. 29, 2018, which claimspriority to U.S. Provisional Patent Application No. 62/527,577, filedJun. 30, 2017, U.S. Provisional Patent Application No. 62/529,996, filedJul. 7, 2017, and U.S. Provisional Patent Application No. 62/529,902,filed Jul. 7, 2017. The entire disclosures of the foregoing areincorporated herein by reference in their entirety.

BACKGROUND OF THE INVENTION

Prosthetic heart valves can be used to treat cardiac valvular disorders.The native heart valves (the aortic, pulmonary, tricuspid and mitralvalves) function to prevent backward flow or regurgitation, whileallowing forward flow. These heart valves can be rendered less effectiveby congenital, inflammatory, infectious conditions, etc. Such conditionscan eventually lead to serious cardiovascular compromise or death. Formany years, the doctors attempted to treat such disorders with surgicalrepair or replacement of the valve during open heart surgery.

A transcatheter technique for introducing and implanting a prostheticheart valve using a catheter in a manner that is less invasive than openheart surgery can reduce complications associated with open heartsurgery. In this technique, a prosthetic valve can be mounted in acrimped state on the end portion of a catheter and advanced through ablood vessel of the patient until the valve reaches the implantationsite. The valve at the catheter tip can then be expanded to itsfunctional size at the site of the defective native valve, such as byinflating a balloon on which the valve is mounted or, for example, thevalve can have a resilient, self-expanding stent or frame that expandsthe valve to its functional size when it is advanced from a deliverysheath at the distal end of the catheter. Optionally, the valve can havea balloon-expandable, self-expanding, mechanically-expandable frame,and/or a frame expandable in multiple or a combination of ways.

Transcatheter heart valves (THVs) may be appropriately sized to beplaced inside many native aortic valves. However, with larger nativevalves, blood vessels (e.g., an enlarged aorta), grafts, etc., aortictranscatheter valves might be too small to secure into the largerimplantation or deployment site. In this case, the transcatheter valvemay not be large enough to sufficiently expand inside the native valveor other implantation or deployment site or the implantation/deploymentsite may not provide a good seat for the THV to be secured in place. Asone example, aortic insufficiency can be associated with difficultysecurely implanting a THV in the aorta and/or aortic valve.

SUMMARY OF THE DISCLOSURE

This summary is meant to provide examples and is not intended to limitthe scope of the invention in any way. For example, any feature includedin an example of this summary is not required by the claims, unless theclaims explicitly recite the feature. The description disclosesexemplary embodiments of trans-catheter implantable device frames, anddocking stations or docking devices for trans-catheter implantabledevices. The trans-catheter implantable device frames and dockingstations/devices can be constructed in a variety of ways. Atrans-catheter device frame can include a device such as a valve. Adocking station or docking device provides a landing zone for atranscatheter device, such as a transcatheter valve.

Docking stations/devices for use in the body or a circulatory system ofthe body (e.g., a heart, native heart valve, blood vessel, vasculature,artery, vein, aorta, inferior vena cava (IVC), superior vena cava (SVC),pulmonary artery, aortic valve, pulmonary valve, mitral valve, tricuspidvalve, etc.) can include at least one sealing portion, frame, and valveseat. The docking station and its frame can be configured or shaped toconform to a shape of a portion of the body in which it is to beimplanted, such as to a shape of an aorta, IVC, SVC, etc. For example,the docking stations and frames herein can be configured to conform toan interior shape of circulatory system (e.g., a blood vessel, aorta,IVC, SVC, pulmonary artery, etc.) when expanded inside the circulatorysystem such that the expandable frame can expand in multiple locations(e.g., 2, 3, 4, 5, 6, 7, 8, or more) to conform to multiple bulges ofthe circulatory system and/or can contracts (e.g., is less expanded, hasa smaller diameter, etc.) in multiple locations (e.g., 2, 3, 4, 5, 6, 7,8, or more) to conform to multiple narrowed regions of the circulatorysystem. Further, whether the anatomy is varied or more uniform, thedocking stations and frames herein can be configured such that, whenexpanded inside the circulatory system, the majority (e.g., more than50%), more than 60%, more than 70%, more than 80%, or more of thedocking station contacts an interior surface of the circulatory systemand distributes the pressure and force exerted by the docking stationover the portion or length of the docking station in contact with theinterior surface. This can be helpful, for example, in treating aorticinsufficiency caused by an enlarging of the aortic valve and/or aorta.

The sealing portion(s) of the various docking stations/devices hereincan be formed and configured in any of the ways described in thisdisclosure, for example, the sealing portion(s) can be integrally formedwith the frame, include a covering/material attached to the frame, orinclude a combination of integral and attached elements/components. Thesealing portion can be configured to contact an interior surface of thecirculatory system (e.g., of a blood vessel, vasculature, aorta, IVC,SVC, heart, native heart valve, aortic valve, pulmonary valve, mitralvalve, tricuspid valve, etc.).

The frame(s) of the various docking stations herein can be made andconfigured in any of the ways described in this disclosure, for example,the frame(s) can be made from nitinol, elgiloy, stainless steel, andcombinations thereof. The frame can be an expandable frame, e.g.,self-expandable, manually-expandable (e.g., balloon-expandable),mechanically expandable, or a combination of these). The frame can beconfigured to conform to an interior shape of a portion of a circulatorysystem (e.g., of a blood vessel, vasculature, heart, native heart valve,etc.) when expanded inside the circulatory system.

Optionally, the frame can comprise a plurality of spring segmentsconnected to a plurality of stent segments. The spring elements cancomprise spring wire and can be compression springs, torsion springs, ortension springs. The stent segments can be integrally formed with thespring elements or attached to the spring elements.

Similarly, the valve seat(s) of the various docking stations herein canalso be formed and configured in any of the ways described in thisdisclosure, for example, the valve seat(s) be integrally formed with theframe, be separately attached, or include a combination of integral andattached elements/components. The valve seat can be connected to theexpandable frame. The valve seat can be configured to support aprosthetic valve (e.g., an expandable transcatheter valve, transcatheterheart valve, transcatheter aortic valve, expandable valve, etc.).

The docking stations/devices described above and elsewhere herein can beused to form a docking assembly or system, e.g., including a graft orother elements. For example, a docking assembly/system (e.g., a dockingdevice assembly, docking station assembly, docking device system, etc.)can include a graft and a docking station/device. The graft can beshaped to conform to a portion of an interior shape of a first portionof a blood vessel (e.g., vein, artery, aorta, etc.). The dockingstation/device and the graft can be coupled to each other. A portion ofthe docking station/device can engage an interior of the graft.

Various docking stations/devices described herein can be used in theassembly and can include an expandable frame, at least one sealingportion, and a valve seat as discussed above, and each of these caninclude features of these types of components described elsewhereherein. The expandable frame can be configured to conform to an interiorshape of a second portion of the blood vessel when expanded inside theblood vessel. The sealing portion can be configured to contact aninterior surface of the circulatory system or blood vessel. The sealingportion can include a covering/material or fabric attached to the frame.The valve seat can be part of and/or connected to the expandable frameand can be configured to support a prosthetic valve (e.g., an expandabletranscatheter valve, transcatheter heart valve, aortic valve, expandablevalve, etc.).

The docking assembly/system can optionally be integrally formed with avalve, e.g., such that the docking station/device and valve combinationis a prosthetic valve or transcatheter prosthetic valve that can beimplanted in the same step.

In one embodiment, a docking station comprises an expandable frameconfigured to conform to an interior shape of a blood vessel (and/orother part of the circulatory system) when expanded inside the bloodvessel. The docking station can comprise at least one sealing portionconfigured to contact an interior surface of the blood vessel. Thedocking station comprises a valve seat, wherein the valve seat isconfigured to support a prosthetic valve or expandable transcathetervalve. The valve seat can be located in radially inside the outer wallof the frame, e.g., overlapping in a radial direction, or can be axiallyspaced from the outer wall so there is no overlap in the radialdirection. The valve seat can be coaxial with the outer wall of theframe.

The valve seat can comprises a first portion of the expandable frame(which can be annular), and links can connect the first portion of theexpandable frame to a second portion of the expandable frame, the secondportion comprising an outer wall (which can be annular). The links canbe curved, e.g., such as in a semi-circular shape, an undulating shape,etc. The entire frame and/or an outer wall of the frame can comprise aplurality of struts. A thickness of the links can be the same as or lessthan a thickness of the struts. The links and the struts can beintegrally formed, and a transition portion can transitions from thethickness of the links to the thickness of the struts.

An apex of the links can be bent such that portions of the links onopposite sides of the apex extend away from each other at an acuteangle. The apex of the links can include an upwardly extending circularportion and/or a downwardly extending circular portion. The links canextend from the first portion of the expandable frame to the secondportion at an angle with respect to a radial direction. The links can betwisted as they extend from the valve seat to the annular wall.

A tubular graft can be coupled to the expandable frame, and the graftcan be configured to extend axially beyond an end of the expandableframe. The frame can comprise a plurality of stent segments connected toa plurality of spring elements. The spring elements consist of springwires, compression springs, torsion springs, tension springs, andcombinations thereof. The struts of the expandable frame can beintegrally formed with the spring elements. The sealing portion and/orvalve seat can be integrally formed with the frame. The expandable framecan include no legs, only one leg, or multiple legs that extendproximally beyond the remainder of the frame. The frame can include anelongated second leg that extends proximally further than an end of thefirst leg.

In one embodiment, an expandable docking station frame comprises anannular valve seat having an end, an annular outer wall comprisingstruts disposed around the valve seat, and links that connect the end ofthe annular valve seat to the annular outer wall. A thickness of thelinks can be the same as or less than a thickness of the struts. Thelinks and the struts can be integrally formed, and can have a transitionportion that transitions from the thickness of the links to thethickness of the struts. The links are curved, e.g., in a semi-circularshape. An apex of the links can be bent such that portions of the linkson opposite sides of the apex extend away from each other at an acuteangle. The apex of the links can include an upwardly extending circularportion and/or a downwardly extending circular portion. The links canextend from the first portion of the expandable frame to the secondportion at an angle with respect to a radial direction. The links can betwisted as they extend from the valve seat to the annular wall. Theexpandable frame can include no legs, only one leg, or multiple legsthat extend proximally beyond the remainder of the frame. The frame caninclude an elongated second leg that extends proximally further than anend of the first leg.

In one embodiment, an expandable docking station frame comprises anannular valve seat having an end, an annular outer wall comprisingstruts disposed around the valve seat, and links that connect the end ofthe annular valve seat to the annular outer wall. The links can betwisted and/or angled as the links extend between the annular outer walland the annular valve seat. A thickness of the links can be the same asor less than a thickness of the struts. The frame and its components(e.g., struts, links, etc.) can have the same or similar features tothose discussed above and elsewhere herein.

In one embodiment, an expandable docking station frame comprises anannular valve seat having an end, an annular outer wall comprisingstruts disposed around the valve seat, and links that connect the end ofthe annular valve seat to the annular outer wall, wherein the linksextend from the valve seat to the annular wall at an angle with respectto a radial direction. The links can be twisted and/or angled as thelinks extend between the annular outer wall and the annular valve seat.A thickness of the links can be the same as or less than a thickness ofthe struts. The frame and its components (e.g., struts, links, etc.) canhave the same or similar features to those discussed above and elsewhereherein.

In one embodiment, a docking station assembly comprises a graftconfigured to conform to an interior shape of a first portion of a bloodvessel when expanded inside the blood vessel, and a docking stationcoupled to the graft. The docking station can comprise an expandableframe configured to conform to an interior shape of a second portion ofthe blood vessel when expanded inside the blood vessel. The dockingstation can comprise at least one sealing portion configured to contactan interior surface of the blood vessel when expanded inside the bloodvessel. The docking station can comprise a valve seat, wherein the valveseat is configured to support an expandable transcatheter valve. Thegraft, frame, sealing portion, and valve seat can have the same orsimilar features to those discussed above and elsewhere herein.

In one embodiment, a docking station comprises a frame configured totransition from a first configuration to a second configuration,wherein, when in the second configuration, at least a first portion ofthe frame is curled, and wherein the frame is configured such that asthe frame transitions from the first configuration to the secondconfiguration, the frame curls back on itself. The docking station isconfigured to capture native leaflets of a native valve as the framecurls back on itself. The docking station can be configured such thatthe native leaflets can be clamped between the valve seat and anotherportion of the docking station. In one embodiment, when in the secondconfiguration, the first portion of the frame can be curled at least 360degrees. In the second configuration, the second end can overlap atleast a portion of the first end. The first configuration of the framecan be a straightened configuration or a configuration in which noportion of the frame is curled. The frame can be configured to be heldin the straightened configuration inside a delivery catheter andprevented from transitioning to the second configuration until exitingthe catheter.

The docking station can also comprise a valve seat configured to supportan expandable transcatheter valve. The valve seat can be formed by innerstruts that extend from a first end of the frame to a junction. Theinner struts can form diamond shaped openings. Top and outer struts canextend from the junction to a second end and form continuous openings.The docking station can also comprise at least one sealing portionconfigured to contact an interior surface of anatomy.

The frame can comprise one or more legs that extend to an end of theframe. The one or more legs can extend from inner struts of the valveseat. The one or more legs can comprise an elongated leg that extendsaxially further than a shorter leg of the one or more legs.

In one embodiment, a docking station comprises a frame comprising aretaining portion circumscribing an inflow area and a valve seatconfigured to support an expandable transcatheter valve, wherein theretaining portion has a first diameter larger than a second diameter ofthe valve seat, and wherein a tapered region transitions between thefirst diameter and the second diameter. The docking station can compriseat least one sealing portion configured to contact an interior surfaceof a circulatory system. The tapered region can be configured totransition between the first diameter of the retaining portion and thesecond diameter of the valve seat in a direction from the inflow area toan outflow area. The frame can comprise a plurality of metal struts thatform cells.

The docking station can comprise a band that extends about the valveseat to cause the valve seat to be unexpandable or substantiallyunexpandable. The valve seat can be configures such that it does notradially overlap any of the retaining portion. The valve seat can bepositioned entirely to one axial side of the retaining portion.

The docking station can further comprise an atraumatic outer segmentthat extends radially outwardly from the valve seat. The outer segmentcan be round and/or toroidal. The outer segment can comprise a pluralityof struts that form cells and/or can comprise a foam material. Thedocking station can comprise a first sealing portion configured toinhibit blood flow between an atrium-vein junction in the body and thedocking station when implanted, and can comprise a second sealingportion configured to inhibit blood flow between the valve seat and atranscatheter valve implanted at the valve seat.

The frame can be configured to conform to an interior shape of bloodvessel, when expanded inside the blood vessel, such that the frame canexpand in multiple locations to conform to multiple bulges of the bloodvessel and multiple narrowed regions of the blood vessel to distributethe pressure on the blood vessel from the docking station over most ofthe length of the docking station. This can be helpful, for example, intreating aortic insufficiency caused by an enlarging of the aortic valveand/or aorta, e.g., where excessive outward pressure on the aortic valveand/or aorta is desired to be avoided. The docking station can comprisea leg that extends axially at an end of the retaining portion, and canfurther comprise an elongated leg that extends axially further from theremainder of the retaining portion than the leg.

A system can comprise a first docking station having a first valve seat,a second docking station having a second valve seat, wherein each of thefirst valve seat and the second valve seat is configured to support anexpandable valve (e.g., an expandable transcatheter valve); and aconnecting portion connecting the first docking station and the seconddocking station together to form a dual docking station. The system cancomprise at least one sealing portion or multiple sealing portionsconfigured to contact one or more interior surfaces of a circulatorysystem. The connecting portion can be configured to allow blood tofreely flow through the connecting portion when the system is implantedin a body. The connecting portion can be integrally formed with thefirst docking station and the second docking station.

The dual docking station can be configured such that the first dockingstation can be implanted in an inferior vena cava of a body and thesecond docking station can be deployed in a superior vena cava of thebody, with a first valve expanded within the first valve seat and asecond valve expanded within the second valve seat. The dual dockingstation can be configured such that the first docking station can beimplanted in an inferior vena cava of a body and the second dockingstation can be deployed in a superior vena cava of the body, with onlyone of the first docking station and the second docking stationreceiving an expandable valve therein.

The system can comprise a first valve expandable within the first valveseat such that the first valve is securely held in the first valve seat.The system can comprise a second valve expandable within the secondvalve seat such that the second valve is securely held in the secondvalve seat.

The system and/or dual docking station can be configured to beadjustable in overall length inside a circulatory system at animplantation site, for example, such that the dual docking station canbe sized during delivery to fit different anatomy (e.g., variousdistances between the IVC and SVC of different patients). Other featuresand components of dual docking stations described elsewhere herein canalso be incorporated.

A docking deployment system/assembly (e.g., a docking station deploymentsystem, docking device deployment system, etc.) can comprise a catheterdefining a delivery passage and having a distal opening. The deploymentsystem can also include a self-expandable docking station capable ofbeing radially compressed and expanded, e.g., between a firstconfiguration and a second configuration or between a compressedconfiguration and an expanded configuration. The docking station can beconfigured to be held in a compressed configuration inside the deliverypassage of the catheter, e.g., until delivery at an implantation site.The deployment system includes a retention device releasably connectableto the docking station. The retention device can be configured toinhibit the docking station from jumping distally out of the catheter.The retention device can be configured to inhibit the docking stationfrom moving axially relative to the retention device and/or a proximalhandle of the system. The retention device can be configured to maintainthe axial position of the docking station until the docking station isfully expanded at an implantation site. In one embodiment, the retentiondevice is a pusher having a distal end connectable to a proximal end ofthe docking station. Features and components of other docking deploymentsystems/assemblies described herein can be included as well.

The docking station can include at least one leg that extends proximallyat a proximal end of the docking station and is releasably connectableto the retention device. The docking station can include multiple legsthat extends proximally at a proximal end of the docking station, andthe multiple legs can be spaced evenly radially around the proximal endof the docking station. The docking station includes only one leg thatextends proximally at a proximal end of the docking station and isreleasably connectable to the retention device, such that the dockingstation can fully expand while the one leg is connected to the retentiondevice and then be released.

The docking station can include a first leg and a second leg that eachextend proximally at a proximal end of the docking station and arereleasably connectable to the retention device, wherein the first leg islonger than the second leg. The retention device, the first leg, and thesecond leg can be configured such that during delivery the retentiondevice first releases the second leg to allow docking station to fullyexpand while the first leg is still connected to the retention device.

The retention device can comprise a lock and release connector having abody and a door, wherein the door is moveable from a first position to asecond position. The lock and release connector can have a second doormoveable from a third position to a fourth position, and wherein thelock and release connector is configured such that it can hold a firstleg of the docking station between the door and the body in the firstposition and can hold a second leg of the docking station between thesecond door and the body in the third position. The retention device cancomprise a lock and release connector having a body and a door, whereinthe door is moveable from a first position to a second position, andwherein the retention device is connected to the docking station whenthe leg is between the door and the body and the door is in the firstposition. The retention device can be configured to release the leg whenthe door is moved to the second position.

The retention device can comprise a retaining line usable to maintainthe position of the docking station as the docking station is deployedfrom the catheter and fully radially expanded.

The retention device comprises a pin (or narrowed portion of a pusher,inner shaft, etc.) that extends inside of at least a proximal end of thedocking station and can inhibit the docking station from jumping out ofa distal end of the catheter. The pin can be configured to inhibit thedocking station from jumping out of the distal end of the catheter byinhibiting the proximal end of the docking station from angling out ofparallel (e.g., with respect to the inner surface of the catheter and/orthe outer surface of the pin/pusher/shaft).

Various features as described elsewhere in this disclosure can beincluded in the examples summarized here and various methods and stepsfor using the examples and features can be used, including as describedelsewhere herein.

Further understanding of the nature and advantages of the disclosedinventions can be obtained from the following description and claims,particularly when considered in conjunction with the accompanyingdrawings in which like parts bear like reference numerals.

BRIEF DESCRIPTION OF THE DRAWINGS

Further understanding of the nature and advantages of the disclosedinventions can be obtained from the following description and claims,particularly when considered in conjunction with the accompanyingdrawings in which like parts bear like reference numerals.

To further clarify various aspects of embodiments of the presentdisclosure, a more particular description of the certain embodimentswill be made by reference to various aspects of the appended drawings.These drawings depict only exemplary embodiments of the presentdisclosure and are therefore not to be considered limiting of the scopeof the disclosure. Moreover, while the figures may be drawn to scale forsome embodiments, the figures are not necessarily drawn to scale for allembodiments. Embodiments of the present disclosure will be described andexplained with additional specificity and detail through the use of theaccompanying drawings.

FIG. 1A is a cutaway view of the human heart in a diastolic phase;

FIG. 1B is a cutaway view of the human heart in a systolic phase;

FIG. 2 is a cutaway view of the human heart with an exemplary embodimentof an exemplary docking station positioned in a blood vessel, theinferior vena cava IVC;

FIG. 2A is an end view of an exemplary docking station and valve showingthe valve in an open configuration such that blood can flow through thevalve, e.g., when the heart is in a diastolic phase;

FIG. 2B is an end view of the docking station and valve of FIG. 2showing the valve in a closed configuration, e.g., when the heart is ina systolic phase;

FIG. 3A is a sectional view of an exemplary embodiment of a dockingstation with an exemplary transcatheter valve disposed inside thedocking station;

FIG. 3B is a top view of the docking station and valve illustrated byFIG. 3A;

FIG. 3C is a perspective view of an exemplary embodiment of a dockingstation that illustrates an example of a frame portion that can be usedin the docking station of FIGS. 3A-3B;

FIG. 3D is a sectional view of the docking station illustrated by FIG.3A where the transcatheter valve shown is representative of a leaflettype transcatheter valve;

FIGS. 4A and 4B schematically illustrate deployment of a dockingstation;

FIGS. 4C and 4D schematically illustrate deployment of a valve in thedocking station;

FIG. 4E schematically illustrates conformance of a docking station to aninner surface having a varying size;

FIG. 5A is a sectional view of an exemplary embodiment of a dockingstation with an exemplary transcatheter valve disposed inside thedocking station;

FIG. 5B is a top view of the docking station and valve illustrated byFIG. 5A;

FIG. 5C is a bottom view of the docking station and valve illustrated byFIG. 5A;

FIG. 6 is a perspective view of an exemplary embodiment of a dockingstation;

FIG. 7A is a sectional view of an exemplary embodiment of a dockingstation with an exemplary transcatheter valve disposed inside thedocking station;

FIG. 7B is a top view of the docking station and valve illustrated byFIG. 7A;

FIG. 8A is a sectional view of an exemplary embodiment of a dockingstation with an exemplary transcatheter valve disposed inside thedocking station;

FIG. 8B is a top view of the docking station and valve illustrated byFIG. 8A;

FIG. 9A is a sectional view an exemplary embodiment of a docking stationwith an exemplary transcatheter valve disposed inside the dockingstation;

FIG. 9B is a top view of the docking station and valve illustrated byFIG. 9A;

FIG. 10 is a perspective view of an exemplary embodiment of a dockingstation;

FIG. 11 is a graph illustrating a relationship between radially outwardforce and the expanded diameter of a docking station frame;

FIG. 12 is a perspective view of an exemplary embodiment of a dockingstation frame;

FIGS. 12A and 12B illustrate enlarged portions of FIG. 12;

FIG. 13 is a perspective view of the docking station frame illustratedby FIG. 12;

FIG. 14 is a perspective view of an exemplary embodiment of a dockingstation frame;

FIG. 15 is a perspective view of a portion of an exemplary embodiment ofa docking station frame;

FIG. 16 is a perspective view of an exemplary embodiment of a linkbetween an inner portion (e.g., valve seat) and an outer portion of thedocking station frame of FIG. 15;

FIG. 17 is a perspective view of a portion of an exemplary embodiment ofa docking station frame;

FIG. 18 is another perspective view of a portion of the docking stationframe of FIG. 17;

FIG. 19 is a perspective view of an exemplary embodiment of a linkbetween an inner portion (e.g., valve seat) and an outer portion of thedocking station frame of FIGS. 17 and 18;

FIGS. 20A-20C show exemplary embodiments of shapes of links or portionsof links that can be used between an inner portion/valve seat and anouter portion of a docking device frame;

FIGS. 21A-21H illustrate an exemplary embodiment of crimping of anexemplary docking station frame;

FIGS. 22A-22C illustrate an exemplary deployment of an exemplary dockingstation;

FIGS. 23A-23C illustrate an exemplary deployment of an exemplary dockingstation;

FIGS. 24A-24C illustrate an exemplary deployment of an exemplary dockingstation;

FIG. 25 is a side elevational view of an exemplary docking stationframe;

FIG. 26 is a perspective view of an exemplary embodiment of a dockingstation frame;

FIG. 27 is a top view of the docking station frame illustrated by FIG.26;

FIG. 28 is a side view of the docking station frame illustrated by FIG.26;

FIG. 29 is a perspective view of an exemplary embodiment of a dockingstation including an exemplary transcatheter valve therein;

FIG. 30 is a sectional view of an exemplary embodiment of a coveringmaterial that can be used with the docking station illustrated in FIG.29;

FIG. 31 is a cutaway view of a human heart showing a portion of a rightatrium and IVC of the human heart with the docking station illustratedby FIG. 29 positioned in the IVC;

FIG. 32 is a perspective view of an exemplary embodiment of a dockingstation;

FIG. 33 is a cutaway view of a human heart with the docking stationillustrated by FIG. 32 positioned in the inferior vena cava;

FIG. 34 is a side view of a portion of an exemplary embodiment of adocking station;

FIG. 35 is a perspective view of the docking station illustrated in FIG.34;

FIG. 36 is a schematic cutaway view of a portion the human heart with anexemplary docking station positioned in the inferior vena cava and theright atrium;

FIG. 37 is a side view of an exemplary embodiment of a docking stationframe or portion;

FIG. 38 illustrates bending of the docking station frame/frame portionof FIG. 37;

FIG. 39 illustrates expansion and contraction of portions of the dockingstation frame/frame portion illustrated by FIG. 37;

FIG. 40 illustrates an exemplary embodiment of frame portions andspring/flexible portions of a docking station;

FIG. 41 illustrates an exemplary embodiment of a docking stationdeployed in a vessel;

FIG. 42 is a cutaway view of the human heart with an exemplaryembodiment of a docking station that extends from the superior vena cavato the inferior vena cava;

FIG. 43 is a cutaway view of the human heart with an exemplaryembodiment of a docking station that extends from the superior vena cavato the inferior vena cava;

FIG. 44 is a cutaway view of the human heart with an exemplaryembodiment of a docking station that extends from the superior vena cavato the inferior vena cava;

FIG. 45 is a cutaway view of the human heart with an exemplaryembodiment of a docking station that extends from the superior vena cavato the inferior vena cava;

FIG. 46 is a cutaway view of the human heart with an exemplaryembodiment of a docking station that extends from the superior vena cavato the inferior vena cava;

FIG. 47 is a view of the docking station of FIG. 46 with sealingportions deployed;

FIG. 48 illustrates an exemplary embodiment of a profile of a dockingstation;

FIG. 49 illustrates an exemplary embodiment of a profile of a dockingstation;

FIG. 50 is a cutaway view of the human heart with the docking stationillustrated by FIG. 49 positioned in the inferior vena cava;

FIG. 51 is a side view of an exemplary embodiment of a docking station;

FIG. 52 is a cutaway view of the human heart with the docking stationillustrated by FIG. 51 positioned in the inferior vena cava;

FIG. 53 is a schematic illustration of an exemplary embodiment of adocking station;

FIG. 54 is a schematic illustration of an exemplary embodiment of adocking station;

FIGS. 55A-55C illustrate three different positions of the dockingstation of FIG. 53;

FIG. 56 is a cutaway view of the human heart with the docking stationillustrated by FIG. 53 positioned in the inferior vena cava;

FIG. 57 is a perspective view of an exemplary embodiment of a dockingstation;

FIG. 58 is a cutaway view of a human heart with the docking stationillustrated by FIG. 57 positioned in the inferior vena cava IVC;

FIG. 59A is a perspective view of an exemplary embodiment of a dockingstation in a partially compressed state;

FIG. 59B illustrates the docking station of FIG. 59B in an expandedstate;

FIG. 59C illustrates an exemplary embodiment of a docking station;

FIG. 59D is a cutaway view of the human heart with the docking stationillustrated by FIG. 59C positioned in the inferior vena cava IVC;

FIG. 60A is a sectional view an exemplary embodiment of a dockingstation with a transcatheter valve disposed inside the docking station;

FIG. 60B is a top view of the docking station and transcatheter valveillustrated by FIG. 60A;

FIG. 60C is a sectional view an exemplary embodiment of a dockingstation with a transcatheter valve disposed inside the docking station;

FIG. 60D is a top view of the docking station and transcatheter valve ofFIG. 60C;

FIG. 60E is a sectional view an exemplary embodiment of a dockingstation with a transcatheter valve disposed inside the docking station;

FIG. 60F is a top view of the docking station and transcatheter valve ofFIG. 60E;

FIG. 60G is a sectional view an exemplary embodiment of a dockingstation with a transcatheter valve disposed inside the docking station;

FIG. 60H is a top view of the docking station and transcatheter valve ofFIG. 60G;

FIG. 60I is a sectional view an exemplary embodiment of a dockingstation with a transcatheter valve disposed inside the docking station;

FIG. 60J is a top view of the docking station and transcatheter valve ofFIG. 60I;

FIGS. 61-64, and 65A-65C illustrate some non-limiting examples of typesof valves that can be deployed in a docking station, e.g., in any one ofthe docking stations herein;

FIGS. 66A and 66B schematically illustrate outward radial expansion of adocking station as the docking station is deployed;

FIG. 67 is a perspective view of an exemplary distal end of an exemplarypusher or retention device;

FIG. 68A is a perspective view of an exemplary embodiment of a dockingstation frame having an elongated leg;

FIG. 68B is a side elevational view of an exemplary embodiment of adocking station frame having an elongated leg;

FIG. 68C is a perspective view of an exemplary embodiment of a dockingstation frame having an elongated leg;

FIG. 69A is a side view of an exemplary embodiment of an extension of aframe, e.g., the frame of FIG. 68A, 68B, or 68C;

FIG. 69B is a side view of an exemplary embodiment of an extension of aframe, e.g., the frame of FIG. 68A, 68B, or 68C;

FIG. 70 is a perspective view of an exemplary distal end of an exemplarypusher or retention device;

FIGS. 71A-71C illustrate an exemplary deployment of an exemplary dockingstation;

FIGS. 72A-72C illustrate an exemplary deployment of an exemplary dockingstation;

FIG. 73A is a perspective view of an exemplary cover for a dockingstation frame;

FIG. 73B is a sectional view of an exemplary cover for a docking stationframe;

FIGS. 74A and 74B illustrate an exemplary installation of an exemplarycover on a docking station;

FIG. 75A is a perspective view of an exemplary cover disposed on aframe;

FIG. 75B is a sectional view of an exemplary cover disposed on a dockingstation frame;

FIG. 76 illustrates an exemplary docking station deployed in acirculatory system;

FIG. 77 is a cutaway view of the human heart with an exemplaryembodiment of a docking station positioned in an aorta of a human heart;and

FIG. 78 is a cutaway view of the human heart with an exemplaryembodiment of a docking station and a reinforcement device positioned inan aorta of a human heart.

DETAILED DESCRIPTION

The following description refers to the accompanying drawings, whichillustrate specific embodiments of the invention. Other embodimentshaving different structures and operation do not depart from the scopeof the present invention. Exemplary embodiments of the presentdisclosure are directed to devices and methods for providing a dockingstation/device or landing zone for a prosthetic valve (e.g., atranscatheter valve, such as a transcatheter heart valve), e.g., valve29. In some exemplary embodiments, docking stations/devices forprosthetic valves or THVs are illustrated as being used within thesuperior vena cava (SVC), inferior vena cava (IVC), or both the SVC andthe IVC, although the docking stations/devices (e.g., dockingstation/device 10, other docking stations/devices herein, modifiedversions of the docking stations, etc.) can be used in other areas ofthe anatomy, heart, or vasculature, such as the tricuspid valve, thepulmonary valve, the pulmonary artery, the aortic valve, the aorta, themitral valve, or other locations. The docking stations/devices describedherein can be configured to compensate for the deployed transcathetervalve or THV being smaller and/or having a different geometrical shapethan the space (e.g., anatomy/heart/vasculature/etc.) in which it is tobe placed. For example, the native anatomy (e.g., the IVC) can be oval,egg shaped, or another shape, while the prosthetic valve or THV can becylindrical.

Various embodiments of docking stations/devices and examples ofprosthetic valves or transcatheter valves are disclosed herein, and anycombination of these options can be made unless specifically excluded.For example, any of the docking stations/devices disclosed, can be usedwith any type of valve, and/or any delivery system, even if a specificcombination is not explicitly described. Likewise, the differentconstructions and features of docking stations/devices and valves can bemixed and matched, such as by combining any docking stationtype/feature, valve type/feature, tissue cover, etc., even if notexplicitly disclosed. In short, individual components of the disclosedsystems can be combined unless mutually exclusive or physicallyimpossible.

For the sake of uniformity, in these Figures and others in theapplication the docking stations are typically depicted such that theright atrium end is up, while the ventricular end or IVC end is downunless otherwise indicated.

FIGS. 1A and 1B are cutaway views of the human heart H in diastolic andsystolic phases, respectively. The right ventricle RV and left ventricleLV are separated from the right atrium RA and left atrium LA,respectively, by the tricuspid valve TV and mitral valve MV; i.e., theatrioventricular valves. Additionally, the aortic valve AV separates theleft ventricle LV from the ascending aorta (not identified) and thepulmonary valve PV separates the right ventricle from the pulmonaryartery PA. Each of these valves has flexible leaflets extending inwardacross the respective orifices that come together or “coapt” in theflowstream to form the one-way, fluid-occluding surfaces. The dockingstations and valves of the present application are described, forillustration, primarily with respect to the inferior vena cava IVC,superior vena cava SVC, and aorta/aortic valve. A defective aorticvalve, for example, can be a stenotic aortic valve and/or suffer frominsufficiency and/or regurgitation. The blood vessels, such as theaorta, IVC, SVC, pulmonary artery, may be healthy or may be dilated,distorted, enlarged, have an aneurysm, or be otherwise impaired.Anatomical structures of the right atrium RA, right ventricle RV, leftatrium LA, and left ventricle LV will be explained in greater detail.The devices described herein can be used in various areas whetherexplicitly described herein or not, e.g., in the IVC and/or SVC, in theaorta (e.g., an enlarged aorta) as treatment for a defective aorticvalve, in other areas of the heart or vasculature, in grafts, etc.

The right atrium RA receives deoxygenated blood from the venous systemthrough the superior vena cava SVC and the inferior vena cava IVC, theformer entering the right atrium from above, and the latter from below.The coronary sinus CS is a collection of veins joined together to form alarge vessel that collects deoxygenated blood from the heart muscle(myocardium), and delivers it to the right atrium RA. During thediastolic phase, or diastole, seen in FIG. 1A, the deoxygenated bloodfrom the IVC, SVC, and CS that has collected in the right atrium RApasses through the tricuspid valve TV and into the RV as the rightventricle RV expands. In the systolic phase, or systole, seen in FIG.1B, the right ventricle RV contracts to force the deoxygenated bloodcollected in the RV through the pulmonary valve PV and pulmonary arteryinto the lungs.

The devices described by the present application can be used tosupplement the function of a defective tricuspid valve and/or to preventtoo much pressure from building up in the RA. During systole, theleaflets of a normally functioning tricuspid valve TV close to preventthe venous blood from regurgitating back into the right atrium RA. Whenthe tricuspid valve does not operate normally, blood can backflow orregurgitate into the right atrium RA, the inferior vena cava IVC, thesuperior vena cava SVC, and/or other vessels in the systolic phase.Blood regurgitating backward into the right atrium increases the volumeof blood in the atrium and the blood vessels that direct blood to theheart. This can cause the right atrium to enlarge and cause bloodpressure to increase in the right atrium and blood vessels, which cancause damage to and/or swelling of the liver, kidneys, legs, otherorgans, etc. A transcatheter valve or THV implanted in the inferior venacave IVC and/or the superior vena cava SVC can prevent or inhibit bloodfrom backflowing into the inferior vena cave IVC and/or the superiorvena cava SVC during the systolic phase.

The length L, diameter D, and curvature or contour may vary greatlybetween the superior vena cava SVC and inferior vena cava IVC ofdifferent patients. The relative orientation and location of the IVCand/or SVC can also vary between patients Further, the size or diameterD can vary significantly along the length L of an individual IVC and/orSVC. Also, the anatomy of the IVC and/or SVC is soft, flexible, anddynamic as compared to other cardiac vessels, such as the aorta. Thissofter, more flexible, and/or more dynamic (moving and/or shapechanging) characteristic of the IVC and SVC make it more difficult for atranscatheter valve frame or a docking station that supports atranscatheter valve to anchor in the IVC and/or the SVC than in theaorta. Further, other regions or other vasculature in other areas of thebody and across patients where docking stations could be used can alsovary significantly in shape and size.

The left atrium LA receives oxygenated blood from the left and rightpulmonary veins, which then travels through the mitral valve to the leftventricle. During the diastolic phase, or diastole, seen in FIG. 1A, theoxygen rich blood that collects in the left atrium LA passes through themitral valve MV by and into the left ventricle LV as the left ventricleLV expands. In the systolic phase, or systole, seen in FIG. 1B, the leftventricle LV contracts to force the oxygen rich blood through the aorticvalve AV and aorta into the body through the circulatory system. In oneexemplary embodiment, the devices described by the present applicationare used to supplement or replace the function of a defective aorticvalve. For example, the devices herein are particularly effective fortreating aortic insufficiency. During diastole, the leaflets of anormally functioning aortic valve AV close to prevent the oxygen richblood from regurgitating back into the left ventricle LV. When theaortic valve does not operate normally, blood backflows or regurgitatesinto the left ventricle LV. A THV implanted in the aortic valve helpsprevent or inhibit blood from back-flowing into the left ventricle LVduring the diastole phase. The length L, diameter, D, and curvature orcontour of the aortic root may vary greatly between different patients,especially if the aorta is a dilated, distorted, or enlarged. Further,the size or diameter D may vary significantly along the length L of anindividual aorta.

Referring to FIGS. 2, 3A, 3B, and 3C, in one exemplary embodiment anexpandable docking station/device 10 includes one or more sealingportions 310, a valve seat 18, and one or more retaining portions 314.The sealing portion(s) 310 provide a seal between the docking station 10and an interior surface 416 (See FIG. 2) of the circulatory system. Thevalve seat 18 provides a supporting surface for implanting or deployinga valve 29 in the docking station 10 after the docking station 10 isimplanted in the circulatory system. Optionally, the docking station 10and the valve 29 can be integrally formed, for example, in oneembodiment, the valve seat 18 can be omitted. When integrally formed,the docking station 10 and the valve 29 can be deployed as a singledevice, rather than first deploying the docking station 10 and thendeploying the valve 29 into the docking station. Any of the dockingstations and/or valve seats 18 described herein can be provided orformed with an integrated valve 29.

The retaining portion 314 helps retain the docking station 10 and thevalve 29 at the implantation position or deployment site in thecirculatory system. The retaining portion 314 can take a wide variety ofdifferent forms. In one exemplary embodiment, the retaining portion 314includes friction enhancing features that reduce or eliminate migrationof the docking station 10. The friction enhancing features can take awide variety of different forms. For example, the friction enhancingfeatures can comprise barbs, spikes, texturing, adhesive, and/or a clothor polymer cover with high friction properties on the retaining portions314. Such friction enhancing features can also be used on any of thevarious docking stations or retaining portions described herein.

Expandable docking station 10 and valve 29 as described in the variousembodiments herein are also representative of a variety of dockingstations and/or valves described herein or that might be known ordeveloped, e.g., a variety of different types of valves could besubstituted for and/or used as valve 29 in the various docking stations.

FIGS. 2, 2A, and 2B illustrate a representative example of the operationof the docking stations 10 and valves 29 disclosed herein. In theexample of FIGS. 2, 2A, and 2B, the docking station 10 and valve 29 aredeployed in the inferior vena cava IVC. However, the docking station 10and valve 29 can be deployed in any interior surface within the heart ora lumen of the body. For example, the various docking stations andvalves described herein can be deployed in the superior vena cava SVC,the tricuspid valve TV, the pulmonary valve PV, pulmonary artery, themitral valve MV, the aortic valve AV, aorta, or other vasculature/lumensin the body.

FIGS. 2 and 2A illustrate the valve 29, docking station 10 and heart H,when implanted in the IVC and the heart H is in the diastolic phase.When the heart is in the diastolic phase, the valve 29 opens. Bloodflows from the inferior vena cava IVC and the superior vena cava SVC,into the right atrium RA. The blood that flows from the inferior venacava IVC flows through the docking station 10 and valve 29 as indicatedby arrows 210. Also, while in the diastolic phase, blood in the rightatrium flows through the tricuspid valve TV, and into the rightventricle RV and valve as indicated by arrows 212. FIG. 2A illustratesspace 228 that represents the valve 29 being open when the heart is inthe diastolic phase. A variety of types of valves can be used that mayopen and close in a variety of ways (e.g., including valves withleaflets of tissue that open then coapt to close), so the drawings aremeant to be representative of a variety of valves that can operate indifferent ways. FIG. 2A does not show the interface between the dockingstation 10 and the inferior vena cava to simplify the drawing. Thecross-hatching in FIG. 2A represents blood flow through the valve 29. Inan exemplary embodiment, blood is prevented or inhibited from flowingbetween the inferior vena cava IVC and the docking station 10 by theseal 310 and blood is prevented or inhibited from flowing between thedocking station 10 and the valve by implanting or seating the valve inthe seat 18 of the docking station 10. In this example, blood onlysubstantially flows or is only able to flow through the valve 29 whenthe valve is open (e.g., in one embodiment, only when the heart is inthe diastolic phase).

FIG. 2B illustrates the valve 29 and docking station 10, when the valve29 is closed (e.g., when implanted in the IVC and the heart H is in thesystolic phase). When implanted in the IVC and the heart is in thesystolic phase, the valve 29 closes. Blood is prevented from flowingfrom the right atrium RA into the inferior vena cava IVC by the valve 29being closed. As such, the closed valve 29 prevents any blood thatregurgitates through the through the tricuspid valve TV during thesystolic phase from being forced into the inferior vena cava IVC. Thesolid area 252 in FIG. 2B represents the valve 29 being closed valve isopen (e.g., in one embodiment, when the heart is in the systolic phase).FIG. 2B is meant to be representative of a variety of valves, eventhough those valves may close in different ways.

In one exemplary embodiment, the docking station 10 acts as an isolatorthat prevents or substantially prevents radial outward forces of thevalve 29 from being transferred to the inner surface 416 of thecirculatory system. In one embodiment, the docking station 10 includes avalve seat 18 that resists expansion, e.g., is not expanded radiallyoutwardly (e.g., the diameter of the valve seat does not increase) or isnot substantially expanded radially outward (e.g., the diameter of thevalve seat increases by less than 4 mm) by the radially outward force ofthe transcatheter valve or valve 29. The valve seat can be configuredsuch that expansion of a THV/valve 29 increases the diameter of thevalve seat only to a diameter less than an outer diameter of the dockingstation 10 when the docking station is implanted. Retaining portions 314and sealing portions 310 can be configured to impart only relativelysmall radially outward forces on the inner surface 416 of thecirculatory system (as compared to the radially outward force applied tothe valve seat 18 by the valve 29). Having a valve seat 18 that isstiffer or less radially expansive than the outer portions of thedocking station (e.g., retaining portions 314 and sealing portions 310),as in the various docking stations described herein, provides manybenefits, including allowing a THV/valve 29 to be implanted invasculature or tissue of varying strengths, sizes, and shapes. The outerportions of the docking station can better conform to the anatomy (e.g.,vasculature, tissue, heart, etc.) without putting too much pressure onthe anatomy, while the THV/valve 29 can be firmly and securely implantedin the valve seat 18 with forces that will prevent or mitigate the riskof migration or slipping.

The docking station 10 can include any combination of one or more thanone different types of valve seats 18, retaining portions 314, and/orsealing portions 310. For example, the valve seat 18 can be a separatecomponent that is attached to the frame 350 of the docking station 10,while the sealing portion is integrally formed with the frame 350 of thedocking station. Also, the valve seat 18 can be a separate componentthat is attached to the frame 350 of the docking station 10, while thesealing portion 310 is a separate component that is also attached to theframe 350 of the docking station. Optionally, the valve seat 18 can beintegrally formed with the frame 350 of the docking station 10, whilethe sealing portion is integrally formed with the frame 350 of thedocking station. Further, the valve seat 18 can be integrally formedwith the frame 350 of the docking station 10, while the sealing portionis a separate component that is attached to the frame 350 of the dockingstation 10.

The sealing portion 310, the valve seat 18, and one or more retainingportions 314 of the various docking stations herein can take a varietyof different forms and characteristics. In FIGS. 3A-3C, an expandableframe 350 provides the shape of the sealing portion 310, the valve seat18, and the retaining portion 314. The expandable frame 350 can take awide variety of different forms. The illustrated expandable frame 350 inFIGS. 3A-3C has an end 362 having an inside diameter 364 and an outsidediameter 366. An annular or cylindrical outer portion or wall 368extends downward from the outside diameter 366 of the end 362. Anannular or cylindrical valve seat or wall 18 extends downward from theinside diameter 364 of the end 362. In the illustrated example, theexpandable frame 350 is an expandable lattice. The expandable latticecan be made in a variety of ways, e.g., with individual wires connectedto form the lattice, braiding, cut from a sheet and then rolled orotherwise formed into the shape of the expandable frame, molded, cutfrom a cylindrical tube (e.g., cut from a nitinol), other ways, or acombination of these.

The frame 350 can be made from a highly flexible metal, metal alloy, orpolymer. Examples of metals and metal alloys that can be used include,but are not limited to, nitinol and other shape memory alloys, elgiloy,and stainless steel, but other metals and highly resilient or compliantnon-metal materials can be used to make the frame 350. These materialscan allow the frame to be compressed to a small size, and then when thecompression force is released, the frame will self-expand back to itspre-compressed diameter and/or the frame can be expanded by inflation ofa device positioned inside the frame. The frame 350 can also be made ofother materials and be expandable and collapsible in different ways,e.g., mechanically-expandable, balloon-expandable, self-expandable, or acombination of these.

The sealing portions can take a wide variety of different forms. In theexample of FIGS. 3A-3C, a covering/material 21 is attached to a portionof the frame 350 to form the sealing portion 310. However, the sealingportion 310 can be formed in a wide variety of other ways. Thecovering/material 21 can be a fabric material, polymer material, orother material. The sealing portion 310 can take any form that preventsor inhibits the flow of blood from flowing around the outside surface ofthe valve 29 and through the docking station. In the example of FIGS.3A, 3B, and 3C, the sealing portion 310 comprises a covering/material 21(e.g., a fabric or other covering material that can be the same as orsimilar to other coverings/materials described herein) that extends upto the valve seat 18. The covering/material 21 can be shaped andpositioned in a variety of ways, e.g., the covering/material can beconfigured to partially cover the valve seat 18, entirely cover thevalve seat 18, or not cover the valve seat 18 when the frame 350 isexpanded. The covering/material 21 (e.g., fabric or other coveringmaterial) that forms the sealing portion 310 can also extend radiallyoutward, covering the end 362 of the frame 350, and can optionallyextend (e.g., longitudinally, downward, etc.) to cover at least aportion of the annular outer portion or wall 368. The sealing portion310 provides a seal between the docking station 10 and an interiorsurface 416 (See FIG. 2) of the circulatory system. That is, the sealingportion 310 and the closed valve 29 prevent or inhibit blood fromflowing in the direction indicated by arrow 377. In the example of FIGS.3A and 3B, blood is not inhibited from flowing in the directionindicated by arrow 378 into the area 379 between the valve seat 18 andthe annular outer portion or wall 368.

The valve seat can take a wide variety of different forms. The valveseat 18 is a portion of the frame 350 in the example of FIGS. 3A-3C.However, the valve seat 18 can be formed separately from the frame 350.The valve seat 18 can take any form that provides a supporting surfacefor implanting or deploying a valve 29 in the docking station 10 afterthe docking station 10 is implanted in the circulatory system. The valveseat can optionally be reinforced with a reinforcing material (e.g., asuture, wire, band, collar, etc. that can circumscribe the valve seat ora portion of the valve seat). The valve 29 is schematically illustratedin FIG. 3A to indicate that the valve 29 can take a wide variety ofdifferent forms. FIG. 3D illustrates the more specific example where thevalve 29 is a leaflet type THV, such as the Sapien 3 valve availablefrom Edwards Lifesciences. In one exemplary embodiment, a valve 29 isintegrated with or replaces the valve seat 18, such that docking station10 is configured as a transcatheter valve that is delivered as a singleunit in the same step (as opposed to first implanting a docking stationsand subsequently implanting a separate valve/THV in the dockingstation). Optionally, any of the docking stations described herein canbe formed as a valve or THV, e.g., with valve tissue or other valvematerial integrated into the docking station.

The retaining portions 314 can take a wide variety of different forms.For example, the retaining portion(s) 314 can be any structure that setsthe position of the docking station 10 in the circulatory system. Forexample, the retaining portion(s) 314 can press against or into theinside surface 416 or contour/extend around anatomical structures of thecirculatory system to set and maintain the position of the dockingstation 10. The retaining portion(s) 314 can be part of or define aportion of the body and/or sealing portion of the docking station 10 orthe retaining portion(s) 314 can be a separate component that isattached to the body of the docking station. The docking station 10 caninclude a single retaining portion 314 or two, or more than tworetaining portions. The retaining portion(s) 314 can include frictionenhancing features as discussed above.

In the example of FIGS. 3A-3C, the retaining portion 314 comprises theannular outer portion or wall 368 of the frame 350. A shape set (e.g., aprogrammed shape of a shape memory material) of annular outer portion orwall 368 can bias the annular outer portion or wall 368 radially outwardand into contact with/against the interior surface 416 of thecirculatory system to retain the docking station 10 and the valve 29 atthe implantation position. In the illustrated embodiment, the retainingportion 314 is elongated to allow a relatively small force to be appliedto a large area of the interior surface 416, while the valve 29 canapply a relatively large force to the valve seat 18. For example, thelength of the retaining portion 314 can be twice, three times, fourtimes, five times, or greater than five times the outside diameter ofthe transcatheter valve. Applying a small radially outward force over alarger area can be sufficient to securely hold the docking station inplace, and this design/configuration can allow the docking station toconform to the unique shape/size of the anatomy and avoid/reduce thelikelihood of damaging relatively weaker native tissue. Thereby thevalve 29 can be securely held in a variety of locations and anatomies(e.g., the docking station of FIGS. 3A-D is usable in the IVC, SVC,aorta, etc.).

In the examples of FIGS. 77 and 78, the retaining portion 314 cancomprise the annular outer portion or wall 368 of the frame 350. A shapeset (e.g., a programmed shape of a shape memory material) of annularouter portion or wall 368 biases the annular outer portion or wall 368radially outward and into contact with/against the interior surface 416of the aorta to retain the docking station 10 and the valve 29 at theimplantation position. In the examples of FIGS. 77 and 78, the shape setcan also be selected to substantially match the shape of a portion ofthe aorta. The retaining portion 314 can be elongated to allow arelatively small force to be applied to a large area of the interiorsurface 416, while the valve 29 can apply a relatively large force tothe valve seat 18, as discussed above.

FIGS. 4A-4D schematically illustrate an exemplary deployment of thedocking station 10 and valve 29 in the circulatory system. Referring toFIG. 4A, the docking station 10 is in a compressed form/configurationand is introduced to a deployment site in the circulatory system. Forexample, the docking station 10, can be positioned at a deployment sitein a SVC, IVC, aorta, or other location. Referring to FIG. 4B, thedocking station 10 is expanded in the circulatory system such that thesealing portion(s) 310 and the retaining portion(s) 314 engage theinside surface 416 of a portion of the circulatory system. Referring toFIG. 4C, after the docking station 10 is deployed, the valve 29 is in acompressed form and is introduced into the valve seat 18 of the dockingstation 10. Referring to FIG. 4D, the valve 29 is expanded in thedocking station, such that the valve 29 engages the valve seat 18 andthe seat 18 of the docking station supports the valve. The dockingstation 10 allows the valve 29 to operate within the expansion diameterrange for which it is designed. In the examples depicted herein, thedocking station 10 is longer than the valve. However, in someembodiments the docking station 10 can be the same length or shorterthan the length of the valve 29. Similarly, the valve seat 18 can belonger, shorter, or the same length as the length of the valve 29.

FIG. 4E illustrates that the inner surface 416 of the circulatorysystem, such as the inner surface of a blood vessel or anatomy of theheart can vary in cross-section size and/or shape along its length. Inan exemplary embodiment, the docking station 10 is configured such thatit can expand radially outwardly to varying degrees along its length Lto conform to shape of the inner surface 416. In one exemplaryembodiment, the docking station 10 is configured such that the sealingportion(s) 310 and/or the retaining portion(s) 314 engage the innersurface 416, even though the shape of the blood vessel or anatomy of theheart vary significantly along the length L of the docking station. Thedocking station can be made from a very resilient or compliant materialto accommodate large variations in the anatomy.

FIGS. 5A-5C and 6 illustrate an exemplary embodiment of an expandabledocking station that is similar to the embodiment of FIGS. 3A and 3B,except blood is inhibited from flowing in the direction indicated byarrow 378 into the area 379 between the valve seat 18 and the annularouter portion or wall 368. Blood can be prevented or inhibited fromflowing into the area 379 in a wide variety of different ways. In theexample of FIGS. 5A-5C, a covering material 500 forms a closed toroidover the frame 350. That is, the covering material 500 covers the endsurface 362 and a span 510 between the end surface 362 and the annularvalve seat or wall 18. As such, the covering material 500 prevents entryor slows entry of blood into the area 379. In the example of FIGS. 5A-5Cand 6, the end surface 362 and the valve seat or wall 18 are offset andthe span 510 is a conical or inclined ring with a hole in the center. Inone exemplary embodiment, an end 362 of the annular outer portion orwall 368 and the valve seat or wall 18 are coplanar or substantiallycoplanar and the end surface 362 is a ring or a disc with a hole in thecenter

FIGS. 7A, 7B, 8A and 8B illustrate additional embodiments where blood isinhibited from flowing between the valve seat 18 and the annular outerwall 368. In the example of FIGS. 7A and 7B, the expandable dockingstation includes an outer frame ring 750 and a separate inner frame ring752, instead of unitary frame 350. A toroid-shaped foam piece 710 fillsthe space 712 between the outer frame ring 750 and the inner frame ring752. The toroid-shaped foam piece 710 is illustrated as filling anentire volume defined by the rings 750, 752, and having the same heightas rings 750 and 752. However, in other exemplary embodiments a heightH1 of the foam piece 710 can be less than or greater than the height H2of the rings 750, 752. Similarly, while the expandable frame rings areillustrated as being the same heights, the heights of each of the framerings can be different, e.g., the outer frame ring 750 can have a largeheight to spread the retaining force across a large area of internalsurface 416. The inner frame ring 752 can have a small height to focusthe radial outward force of the valve on a small area of the inner framering 752.

In the example of FIGS. 7A and 7B, the sealing portion 310 comprises thefoam piece 710 and the outer ring 750. The outer ring 750 also acts asthe retaining portion 314 against the inner surface 416. The inner ring752 acts as the valve seat 18.

The inner and outer expandable frames 750, 752 can take a wide varietyof different forms. The expandable frames 750, 752 can be an expandablelattice. The expandable lattice can be made from individual wires, cutfrom a sheet and then rolled or otherwise formed into the shape of theexpandable frame, cut from a cylinder/tube/cylindrical sheet, molded,etc. The frames 750, 752 can be made from a highly flexible metal, metalalloy, or polymer. Examples of metals and metal alloys that can be usedinclude, but are not limited to, nitinol and other shape memory alloys,elgiloy, and stainless steel, but other metals and highly resilient orcompliant non-metal materials can be used to make the frame 750, 752.These materials can allow the frame to be compressed to a small size,and then when the compression force is released, the frame willself-expand back to its pre-compressed diameter and/or the frames can beexpanded by inflation of a device/balloon.

An example of an open cell foam that can be used to form foam piece 710(or any other foam parts mentioned in this application) of the dockingstation is a bio-compatible foam, such as a polyurethane foam (e.g., asmay be obtained from Biomerix, Rockville, Md.). The docking stationswith the foam piece 710 can be self expanding and/or expandable with aninflatable device to cause the docking station to engage an innersurface 416 having a variable shape.

FIGS. 8A and 8B illustrate an exemplary embodiment of a docking station10 that is substantially the same as the docking station of FIGS. 7A and7B, except the inner frame ring 752 is omitted. In the example of FIGS.8A and 8B, the inner surface 810 of the foam piece 710 acts as the valveseat 18. The inner surface 810 of the foam piece 710 can form a valveseat in a wide variety of different ways. For example, the inner surface810 can be made to be substantially inelastic or unexpandable from apredetermined deployed size. For example, the inner surface can beprovided with an inelastic or substantially inelastic skin, which can bemade from the same polymer as the foam (or another polymer), or theinner surface 810 can include a band, ring, or strand. The valve seat 18can be any material capable of supporting the radially outward force ofthe transcatheter valve 29.

FIGS. 9A and 9B illustrate an exemplary embodiment of a docking station10 that is substantially the same as the docking station of FIGS. 8A and8B, except the outer frame ring 750 is omitted. In the example of FIGS.9A and 9B, the outer surface 910 of the foam piece 710 acts as thesealing and retaining portions 310, 314.

FIG. 10 is a perspective view of a docking station 10 that includes afoam piece 710. The docking station of FIG. 10 can include both theinner frame ring 7520 and the outer frame ring 750, the outer frame ring750 only, the inner frame ring 752 only, or no frame ring.

FIGS. 6-10 can be separate docking stations or form a portion of anotherdocking station, e.g., part of one of the docking stationsdescribed/shown elsewhere herein. For example, the embodiments shown inFIGS. 6-10 can be used as or can form an end portion (e.g., regionincluding and around the valve seat) of any of the docking stationsshown in FIGS. 3A-3D, 12-18, 32-36, 42-45, (can be used at either end orboth ends), and 60A-60J, etc., and can be integral or attached.

Optionally, the docking station frame 350 in the various embodimentsherein can be made from an elastic or superelastic material or metal.One such metal is nitinol. When the frame 350 of the docking station 10is made from a lattice of metal struts, the body can have thecharacteristics of a spring. Referring to FIG. 11, like a spring, whenthe frame 350 of the docking station 10 is unconstrained and allowed torelax to its largest diameter the frame of the docking station applieslittle or no radially outward force. As the frame 350 of the dockingstation 10 is compressed, like a spring, the radially outward forceapplied by the docking station increases.

As is illustrated by FIG. 11, in one exemplary embodiment therelationship of the radially outward force of the docking station frame350 to the diameter of the docking station is non-linear, though it canalso be linear. In the example of FIG. 11, the curve 1150 illustratesthe relationship between the radially outward force exerted by thedocking station 10 and the compressed diameter of the docking station.In the region 1152, the curve 1150 has a low slope. In this region 1152,the radially outward force is low and changes only a small amount. Inone exemplary embodiment, the region 1152 corresponds to a diameterbetween 25 mm and 40 mm, such as between 27 mm and 38 mm. The radiallyoutward force is small in the region 1152, but is not zero. In theregion 1154, the curve 1150 has a higher slope. In this region 1154 theradially outward force increases significantly as the docking station iscompressed. In one exemplary embodiment, the body of the stent isconstructed to be in the low slope region 1152 for both a largest vesselaccommodated by the docking station 10 and a smallest vessel. Thisallows the sealing and retaining portions 310, 314 to apply only a smallradially outward force to the inner surface 416 of the circulatorysystem over a wide range of implantation diameters.

The docking station frame 350 can take a wide variety of differentforms. FIGS. 12, 13 and 14 illustrate exemplary embodiments of dockingstation frames. In FIG. 12, a portion of the valve seat 18 is omitted,but the frame includes legs 1250 for supporting a valve seat 18 orforming a portion of a valve seat. In FIGS. 13 and 14 two examples ofvalve seats 18 are shown connected to the legs 1250. In FIG. 13, thevalve seat 18 comprises a separate valve seat component attached to thelegs 1250. In FIG. 14, the valve seat 18 is integrally formed with thelegs 1250. In other embodiments, the valve seat 18 isreplaced/integrated with a valve/THV 29 and the docking station 10 andvalve/THV are configured and deployed as a single unit. In FIG. 14, aportion of the annular outer wall 368 is removed to show the integrallyformed valve seat 18.

In one exemplary embodiment, a thickness of struts 1200 of the framevaries. A wide variety of different portions of the struts 1200 can varyand the struts can vary in different ways. Referring to FIGS. 12A and12B, in one exemplary embodiment a strut 1200 has a first thickness T1and a second thickness T2. In the illustrated example, the struts 1200of the annular wall portion 314 have the first thickness T1 and strutportions or links 1202 of the struts 1200 that form the end 362 have thesecond thickness T2. In this example, the thickness T2 is less than thethickness T1. This reduced thickness allows the end 362 to bend or flexmore easily and connect the annular outer portion or wall 368 to thevalve seat 18. In the illustrated example, the thicknesses T1, T2 aremeasured in the radial outward direction (i.e. measured from an insidesurface of the frame 350 to the outside surface). In one exemplaryembodiment, the width of the struts 1200 is also reduced with thethickness reduction or, optionally, the width of the strut portions canbe reduced instead of the thickness reduction. The thickness T2 can be90% or less of the thickness T1, the thickness T2 can be 80% or less ofthe thickness T1, thickness T2 can be 70% or less of the thickness T1,thickness T2 can be 60% or less of the thickness T1, thickness T2 can behalf or less of the thickness T1, thickness T2 can be 40% or less of thethickness T1, thickness T2 can be 30% or less of the thickness T1,thickness T2 can be ¼ or less of the thickness T1, or the thickness T2can be 20% or less of the thickness T1.

In the illustrated example, the entirety of the strut portions or links1202 of the struts 1200 that form the end 362 have the second thicknessT2. However, in other embodiments, only part of the portions/links 1202that form the end 362 have the reduced thickness. For example, thethickness of the portions/links 1202 can have the thickness T2 at thetop or apex 1204 of the illustrated bend 1206 while another part(s) canhave the thickness T1. In one embodiment, a taper 1210 transitions thestruts 1200 or strut portions/links 1202 from the thickness T1 to thethickness T2. In one embodiment, the taper is more gradual (e.g., occursover a longer distance or length) and extends into the bend of the links1206. The thickness can also increase (e.g., taper) in the area from thetop or apex 1204 to the valve seat 18 or area where the valve seat willbe attached.

The length of the retaining portion 314 in FIGS. 12-13 is shows as beingmany times both the length/height of the valve seat and diameter of thevalve seat. As discussed previously, this configuration applies arelatively small radially outward force over a larger area to theinterior surface of the circulatory system and is sufficient to securethe docking station in place against the interior surface. Further, thisdesign/configuration allows the docking station to conform to the uniqueshape/size of the anatomy expanding more or less in many differentlocations to adjust to the contours (e.g., bulges, narrowed regions,contractions, etc.) of the interior surface of the circulatory system(e.g., blood vessel) and contact more of the interior surface. In oneembodiment, the docking station and frame are configures such that, whenimplanted, all or most of the outer surface of the docking station orframe contacts the interior surface of the circulatory system (even whenirregular or varied in shape). This also helps avoid/reduce thelikelihood of damaging relatively weaker native tissue (e.g., by havingtoo much localized force and/or pressure in one, two, or more particularlocations). Thereby the valve 29 can be securely held in a variety oflocations and anatomies.

For example, the frame shown in FIGS. 12, 13, and 14 is configured suchthat a docking station incorporating this frame can conform to aninterior shape of circulatory system when expanded inside the bloodvessel such that the expandable frame can expand in multiple locations(e.g., 2, 3, 4, 5, 6, 7, 8, or more) to conform to multiple bulges ofthe circulatory system and/or can contracts (e.g., is less expanded, hasa smaller diameter, etc.) in multiple locations (e.g., 2, 3, 4, 5, 6, 7,8, or more) to conform to multiple narrowed regions of the circulatorysystem. Further, whether the native anatomy is varied or more uniform,the frame is configured such that, when a docking station incorporatingthe frame is expanded in the circulatory system, the majority (e.g.,more than 50%), more than 60%, more than 70%, more than 80%, 50-90%, ormore of an outer surface of the docking station contacts an interiorsurface of the circulatory system and distributes the pressure and forceexerted on the interior surface by the docking station over the portionor length of the outer surface of the docking station in contact withthe interior surface.

Referring to FIGS. 15 and 16, in one exemplary embodiment the strutportions or links 1202 that form the end 362 of the frame 350 aretwisted or otherwise angled. The portions/links 1202 can be twisted in awide variety of different ways and can be twisted along their fulllength or just a portion of their length. The twists 1500 aid incrimping or compressing of the frame 350. In the illustrated example, atwist 1500 is included at or near (e.g., adjacent) the junction 1510 ofthe portion/link 1202 and the annular outer portion or wall 368 and ator near (e.g., adjacent) the junction 1520 of the portion/link 1202 andthe valve seat 18. However, in other embodiments a twist 1500 can beprovided at only one of the junction 1510 and the junction 1520. In theillustrated example, the twists 1500 are ninety degree twists, formingone-hundred-eighty total degrees of twist. At the junction 1510 thethickness T1 is greater than the width W1 of the portion/link 1202. Atthe junction 1520 the thickness T2 is greater than the width W2 of theportion/link 1202. Due to the two twists 1500, at the apex 1204, thethickness T3 can be less than the width W3, even though the portion/link1202 is uniform at the apex 1204. That is, due to the twists 1500, thewidths W1, W2 at the junctions 1510, 1520 can become the thickness T3 atthe apex 1204 and the thicknesses T1, T2 at the junctions 1510, 1520 canbecome the width W3. The thickness T3 can be 90% or less of the widthW3, the thickness T3 can be 80% or less of the width W3, thickness T3can be 70% or less of the width W3, thickness T3 can be 60% or less ofthe width W3, thickness T3 can be half or less of the width W3,thickness T3 can be 40% or less of the width W3, thickness T3 can be 30%or less of the width W3, thickness T3 can be ¼ or less of the width W3,or the thickness T3 can be 20% or less of the width W3. Optionally,twists 1500 and a strut portion/link 1202 could be used that have auniform or equal thickness with other struts 1200 of the frame.

The twists 1500 make the frame 350 easier to crimp or compress. Forexample, a thinner thickness T3 at the apex 1204 makes theportions/links 1202 easier to bend at the apex 1204 and along theirlength. In addition, the angles and/or twists 1500 facilitateoffsetting/rotation 1550 of the valve seat 18 relative to the annularouter portion or wall 368. This offsetting/rotation 1550 reduces theamount of bending and axial outward movement 1560 needed whencompressing or crimping the frame 350. As a result, a radius ofcurvature of the apex 1204 of the compressed or crimped frame is greaterthan would be the case if the twists 1500 were not included. Since theradius of curvature is increased, the stress on the apex 1204 is reducedwhen the frame is compressed or crimped.

Referring to FIGS. 17-19, in one exemplary embodiment the frame 350includes a valve seat 18 that is offset or rotated 1700 relative to theannular outer portion or wall 368. This offset or rotation 1700 anglesand/or twists the portions/links 1202. The offset/rotation 1700 aids incrimping or compressing of the frame 350. Any degree of offset orrotation can be implemented. For example, compared to a strutportion/link 1202 of FIG. 13 that extends from the annular outer portionor wall 368 directly toward a longitudinal or center axis A that runslongitudinally through the center of the docking station (e.g., the axisparallel to the outer wall 368 and in the center thereof), theoffset/rotation 1700 can, optionally, cause each of the strutportions/links to be angled 80 degrees or less, 70 degrees or less, 60degrees or less, 50 degrees or less, 40 degrees or less, 30 degrees orless, 20 degrees or less or 10 degrees or less relative to a radial linebetween the longitudinal or center axis A and the junction of the strutportion to the outer wall (e.g., relative to links or strut portionsshown in FIG. 13, which are parallel to such a radial line).

In FIGS. 17-19, at the junction 1710 the thickness T1 is less than thewidth W1 of the strut 1200. At the junction 1720 the thickness T2 isless than the width W2 of the strut 1200. At the apex 1204 the thicknessT3 is also less than the width W3. In one exemplary embodiment, thewidths W1, W2, W3 are all the same. In one exemplary embodiment, thethicknesses T1, T2, T3 are all the same. The thickness T3 can be 90% orless of the width W3, the thickness T3 can be 80% or less of the widthW3, thickness T3 can be 70% or less of the width W3, thickness T3 can be60% or less of the width W3, thickness T3 can be half or less of thewidth W3, thickness T3 can be 40% or less of the width W3, thickness T3can be 30% or less of the width W3, thickness T3 can be ¼ or less of thewidth W3, or the thickness T3 can be 20% or less of the width W3.

The offset/rotation 1700 makes the frame 350 easier to crimp orcompress. For example, the offset/rotation 1700 reduces the amount ofbending and axial outward movement 1760 needed when compressing orcrimping the frame 350. As a result, a radius of curvature of the apex1204 of the compressed or crimped frame is greater than would be thecase if the offset/rotation 1700 were not included. Since the radius ofcurvature is increased, the stress on the apex 1204 is reduced when theframe is compressed or crimped.

Referring to FIGS. 20A-20C, in some exemplary embodiments the apex 1204of the strut portion or link 1202 (See FIG. 12) is shaped to make theframe 350 easier to compress or crimp. The apex 1204 can have a widevariety of different shapes. In the example of FIG. 20A, the apexincludes a sharp bend 2000. Leg portions 2010 form an acute angle (3,such as less than 60 degrees, less than 45 degrees, or less than 30degrees. In the example of FIG. 20B, the apex 1204 includes an upwardlyextending rounded end or tip 2020 that transitions to two leg portions2010 at two bends 2022. The rounded end or tip 2020 is substantiallycircular. For example, the rounded end or tip can be formed by a 180degree to 300 degree (or any sub-range) arc. Leg portions 2010 form anacute angle θ, such as less than 60 degrees, less than 45 degrees, lessthan 30 degrees, less than 20 degrees, or less than 10 degrees. In theexample of FIG. 20C, the apex 1204 includes a downwardly extendingrounded end 2030, two upwardly extending rounded portions 2032, and twoleg portions 2010. The downwardly extending end 2030 is substantiallycircular. For example, the end 2030 can be formed by a 180 degree to 300degree (or any sub-range) arc. The upwardly extending rounded portions2032 are also substantially circular. For example, the upwardlyextending rounded portions can be formed by a 180 degree to 300 degree(or any sub-range) arc. Leg portions 2010 form an acute angle α, such asless than 60 degrees, less than 45 degrees, less than 30 degrees, lessthan 20 degrees, or less than 10 degrees.

FIGS. 21A-21H illustrate crimping of a docking station frame 350, suchas the docking station frame illustrated by FIGS. 17-19 for installationinto a delivery catheter (See for example delivery catheter 2200 in FIG.22A). Depending on the implantation site, the catheter can be flexibleor rigid. A rigid or substantially rigid catheter can be used to accessthe inferior vena cava IVC or the superior vena cava SVC. A percutaneouspath to the inferior vena cava IVC that is relatively straight can beused. In the example, a crimping apparatus 2100 includes a housing 2101and wedge shaped drive members 2102. In FIG. 21A, the docking stationframe 350 is in a fully expanded or substantially fully expandedcondition inside the wedge shaped driving members 2102. In thisposition, both annular outer portion or wall 368 and the valve seat 18are fully expanded. The strut portions/links 1202 are shown angled in agenerally clockwise direction 2110 as they extend from the valve seat 18to the annular outer portion or wall 368. Optionally, the portions/links1202 can be angled in a generally counter-clockwise direction (i.e.,opposite clockwise direction 2110) as they extend from the valve seat 18to the annular outer portion or wall 368 (crimping would be similar butopposite to that shown in FIGS. 21A-21H).

In FIG. 21B, the wedge shaped driving members 2102 begin to move theannular outer portion 368 or wall radially inward. As the annular outerportion 368 moves radially inward, the junctions 1710 (See FIG. 17)moves radially inward and the strut portions/links 1202 force a top end2120 of the valve seat 18 radially inward, while a bottom/proximal end2122 of the valve seat remains substantially expanded.

In FIG. 21C, the wedge shaped driving members 2102 continue to move theannular outer portion 368 or wall radially inward. As the annular outerportion 368 moves radially inward, the junction 1710 (See FIG. 17)continues to move radially inward. The strut portions/links 1202continue to force the top end 2120 of the valve seat 18 radially inward,while a bottom end 2122 of the valve seat remains substantiallyexpanded. As can be seen by comparing FIGS. 21A-21C, the orientation ofthe portions/links 1202 has changed such that the angle in the clockwisedirection 2110 has been diminished, eliminated, or the portions/links1202 extend in the counterclockwise direction. As frame 350 iscompressed or crimped, the radii of curvature of the apexes 1204 becomessmaller.

In FIG. 21D, the wedge shaped driving members 2102 continue to move theannular outer portion 368 or wall radially inward. As the annular outerportion 368 moves radially inward, the junction 1710 (See FIG. 17)continues to move radially inward. The portions/links 1202 force the topend 2120 of the valve seat 18 substantially closed, while a bottom end2122 of the valve seat remains open. In FIG. 21D, the bottom end 2122 ofthe valve seat is in contact with the annular outer portion 368. Theorientation of the strut portions/links 1202 has now clearly changedfrom the clockwise direction 2110 to the counterclockwise direction 2130as they extend from the valve seat 18 to the annular outer portion orwall 368. The radii of curvature of the apexes 1204 continues to becomesmaller. However, the angled orientation of the portion/links 1202 helpskeep the distance between the junctions 1710, 1720 larger to increasethe radii of curvature of the apexes 1204 relative to non-angledportions 2102 that are crimped.

In FIG. 21E, the wedge shaped driving members 2102 drive the annularouter portion 368 and the bottom end 2122 of the valve seat 18 radiallyinward. The orientation of the portions/links 1202 is in thecounterclockwise direction 2130. The radii of curvature of the apexes1204 continue to become smaller.

In FIG. 21F, the wedge shaped driving members 2102 continue to drive theannular outer portion 368 and the bottom end 2122 of the valve seat 18radially inward. The orientation of the portions/links 1202 is in thecounterclockwise direction 2130. The radii of curvature of the apexes1204 continue to become smaller.

In FIG. 21G, the wedge shaped driving members 2102 continue to drive theannular outer portion 368 and the bottom end 2122 of the valve seat 18radially inward. The orientation of the portions/links 1202 is in thecounterclockwise direction 2130. The radii of curvature of the apexes1204 continue to become smaller.

The wedge shaped driving members 2102 continue to drive the annularouter portion 368 and the bottom end 2122 of the valve seat 18 radiallyinward. The radii of curvature of the apexes 1204 continue to becomesmaller. The frame 350 is in the fully compressed or crimped state inFIG. 21H. The compressed or crimped frame 350 can be loaded into acatheter or a sleeve/sheath for deployment into a patient.

Referring to FIGS. 22A-22C, 23A-23C, and 24A-24C, in some exemplaryembodiments the docking station 10 can be configured to curl back onitself as it is deployed from a catheter 2200. The docking stations 10illustrated by FIGS. 22A-22C and 23A-23C can be deployed in any of theinterior surfaces 416 or implantation locations mentioned herein. Thedocking station 10 illustrated by FIGS. 24A-24C is configured fordeployment in a native valve. FIGS. 22A-22C, 23A-23C, and 24A-24Cschematically illustrate a cross-section of a docking station 10 beingdeployed from the catheter 2200. The docking station 10 can be made fromany combination of the materials disclosed herein. For example, thedocking station 10 can be made from a shape memory alloy frame, foam,fabric coverings, etc. The illustrated docking station 10 defines avalve seat 18, a sealing portion 310, and a retaining portion 314.Embodiments shown only in cross-section in this application can beassumed to have an annular or cylindrical shape.

Referring to FIG. 22A, during deployment, the docking station 10 firstextends radially outward 2220 from the deployment catheter 2200.Referring to FIG. 22B, the docking station 10 then extends or curls back2222 toward the deployment catheter. Referring to FIG. 22C, the dockingstation 10 then extends back up 2224 to overlap the last portion 2226 ofthe docking station to be deployed from the catheter 2200.

FIGS. 23A-23C illustrate another exemplary embodiment of a dockingstation 10 that is configured to curl back on itself as it is deployedfrom a catheter 2200. The docking station 10 illustrated by FIGS.23A-23C can be deployed in any of the interior surfaces 416 mentionedherein. Referring to FIG. 23A, during deployment, the docking station 10first extends radially outward 2220 from the deployment catheter 2200.Referring to FIG. 23B, the docking station 10 then extends or curls back2222 toward the deployment catheter. Referring to FIG. 23C, the dockingstation 10 then extends back up 2224 to overlap a valve seat 18 of thedocking station and a last portion 2228 of the docking station to bedeployed extends radially outward 2230 below the curled toroidal portion2230.

FIGS. 24A-24C illustrate another exemplary embodiment of a dockingstation 10 that is configured to curl back on itself as it is deployedfrom a catheter 2200. In the example of FIGS. 24A-24C, the dockingstation 10 is configured to curl back on itself and capture one or moreleaflets 2400 of a native valve. For example, the docking station 10 canbe configured to capture the leaflets of a mitral valve MV, aortic valveAV, tricuspid valve TV, or the pulmonary valve PV. Referring to FIG.24A, from inside the leaflets 2400 of the native valve, the dockingstation 10 deploys and extends radially outward 2420 from the deploymentcatheter 2200 outward of the leaflets 2400. Referring to FIG. 24B, thedocking station 10 then extends or curls back 2422 toward and behind theleaflets 2400. Referring to FIG. 24C, the docking station 10 thenextends back 2424 and the leaflets are sandwiched or clamped 2426between the valve seat 18 and the portion 2428 of the docking station.The clamping secures the docking station 10 to the valve leaflets andthereby the native valve.

FIG. 25 illustrates an example of a strut configuration that can beemployed to make or be incorporated in the curling docking station 10 ofFIGS. 22A-22C and 24A-24C. In FIG. 25, the valve seat 18 is formed byinner struts 2500. The inner struts 2500 extend from an end 2502 to ajunction 2504 and form generally diamond shaped openings 2506. Top andouter struts 2510 extend from the junction 2504 to a second end 2512.The top and outer struts 2510 form continuous openings 2516. Optionally,the end 2512 can extend back up 2224 to overlap the end 2502.

FIGS. 26-28 illustrate an example of a strut configuration that can beemployed to make or be incorporated in the curling docking station 10 ofFIGS. 23A-23C. In FIG. 25, the valve seat 18 is formed by inner struts2600. The inner struts 2600 are elongated and extend (e.g.,longitudinally and radially outward) to form legs 2601 that extend to anend 2602. The inner struts also extend upward to a junction 2604 andform openings 2606. Top and outer struts 2610 extend from the junction2604 to a second end 2612. The top and outer struts 2610 form continuousopenings 2616. In one embodiment, end 2612 extends back up 2224 andoverlaps the legs 2601.

FIG. 29 illustrates an exemplary embodiment of a docking station 10. Theframe 350 or body can take a wide variety of different forms and FIG. 29illustrates just one of the many possible configurations. In the exampleof FIG. 29, the retaining portion 314 forms a relatively wider inflowportion 2912. A relatively narrower portion 2916 forms the seat 18. Atapered portion 2918 joins the wider portion 2912 and the seat 18.

In the example of FIG. 29, the frame 350 comprises a plurality of metalstruts 1200 that form cells 2904. In the example of FIG. 29, cells ofthe retaining portion 314 are uncovered. A covering/material 21 (e.g.,an impermeable material, a semi-permeable material, a material likethose discussed above, etc.), such as a cloth or fabric (FIG. 29) or aprotective foam (FIG. 30) is provided over the narrow portion 2916, thetapered portion 2918, and the round or outer segment 3216 to form thesealing portion 310 of the docking station 10. The valve 29 expands inthe narrow portion 2916, which forms the valve seat 18.

The docking station can be made from a very resilient or compliantmaterial to accommodate large variations in the anatomy. For example,the docking station can be made from a highly flexible metal, metalalloy, polymer, or an open cell foam. An example of a highly resilientmetal is nitinol, but other metals and highly resilient or compliantnon-metal materials can be used. The docking station 10 can be selfexpandable, manually expandable (e.g., expandable via balloon),mechanically expandable, or a combination of these. A self-expandabledocking station 10 can be made of a shape memory material such as, forexample, nitinol.

Referring to FIG. 29, in one exemplary embodiment, a band 20 extendsabout the waist or narrow portion 2916, or is integral to the waist toform an unexpandable or substantially unexpandable valve seat 18. Theband 20 stiffens the waist and, once the docking station is deployed andexpanded, makes the waist/valve seat relatively unexpandable in itsdeployed configuration. Optionally the band 20 can extend over some orall of the narrow portion 2916. In the example of FIG. 29, the valve 29is secured by expansion of its collapsible frame into the valve seat 18,of the docking station 10. The unexpandable or substantiallyunexpandable valve seat 18 prevents the radially outward force of thevalve 29 from being transferred to the inside surface 416 of thecirculatory system. However in one exemplary embodiment, the waist/valveseat of the deployed docking station can optionally expand slightly inan elastic fashion when the valve 29 is deployed against it. Thisoptional elastic expansion of the waist 18 can put pressure on the valve29 to help hold the valve 29 in place within the docking station.

The band 20 can take a wide variety of different forms and can be madefrom a wide variety of different materials. For example, the band 20 canbe made of PET, PTFE, ePTFE, one or more sutures, fabric, metal,polymer, a biocompatible tape, or other relatively unexpandablematerials known in the art that are sufficient to maintain the shape ofthe valve seat 18 and hold the valve 29 in place. The band can extendabout the exterior of the stent, or can be an integral part of it, suchas when fabric or another material is interwoven into or through cellsof the stent. The band 20 can be narrow, such as the suture band in FIG.29, or can be wider. The band can be a variety of widths, lengths, andthicknesses. In one non-limiting example, the valve seat 18 is between15-35 mm wide, 18-31 mm wide, 20-29 mm wide, etc., although the diameterof the valve seat should be within the operating range of the particularvalve 29 that will be secured within the valve seat 18, and can bedifferent than the foregoing example. The valve 29, when docked withinthe docking station, can optionally expand around either side of thevalve seat slightly. This aspect, sometimes referred to as a “dogbone”(e.g., because of the shape it forms around the valve seat or band), canalso help hold the valve in place.

FIG. 31 illustrates the docking station 10 of FIG. 29 implanted in thecirculatory system, such as in the inferior vena cava IVC. In theexample of FIG. 31, the narrow portion 2916 and/or the tapered portion2918 extend into the right atrium RA and the retaining portion 314(hidden in FIG. 31) is held in place in the inferior vena cava IVC. Thereduced size of the narrow portion 2916 can prevent the docking station10 from contacting an interior surface of the circulatory system ornative tissue (e.g., of the right atrium RA). The covering 21illustrated by FIG. 30 can be used to cushion any contact between thenarrow portion 2916 and the circulator system or native tissue (e.g.,right atrium) that might occur. The sealing portion 310 provides a sealbetween the docking station 10 and an interior surface 416 of thecirculatory system, such as at the junction between the inferior venacava IVC and the right atrium.

In the example of FIG. 31, the sealing portion 310 is formed byproviding the covering/material 21 over the frame 350 or a portionthereof. In particular, the sealing portion 310 can comprise the narrowportion 2916, the tapered portion 2918 and/or the retaining portion 314.In an exemplary embodiment, the covering/material 21 (e.g., animpermeable material, semi-permeable material, cloth, polymer, foam,wax, etc.) covers the narrow portion 2916, the tapered portion 2918, andoptionally a portion of the retaining portion 314. In one embodiment,the covering/material can be configured to encourage or enhance tissueingrowth (e.g., covering/material 21 can have a large surface areaand/or be hydrophilic to enhance tissue ingrowth). This provides a sealand makes the docking station impermeable or substantially impermeablefrom the sealing portion 310 to the seal between the valve 29 and thedocking station 10 at the valve seat 18. As such, blood flowing in theinflow direction 12 toward the outflow direction 14 is directed to thevalve seat 18 and valve 29, once installed/deployed in the valve seat.

As one non-limiting example, when the docking station 10 is placed inthe inferior vena cava, which is a large vessel, the significant volumeof blood flowing through the vein is funneled into the valve 29 by thecovering 21. The covering 21 can be fluid impermeable or become fluidimpermeable (e.g., via tissue ingrowth) so that blood cannot passthrough. A variety of other covering materials (including any materialsdescribed elsewhere herein), can be used such as, for example, foam(FIG. 30) or a fabric that is treated with a coating that is impermeableto blood, polyester, or a processed biological material, such aspericardium. More of the docking station frame 350 can be provided withthe material 21, forming a relatively large impermeable portion.

FIG. 32 illustrates an exemplary embodiment of a docking station 10. Thedocking station illustrated by FIG. 32 is similar to the docking stationillustrated by FIG. 29, except an outer segment 3216 extends from thenarrow portion 2916. The outer segment 3216 is shaped to be atraumaticto the interior surface 416 or native anatomy. For example, the outersegment 3216 can be round or toroidal. The round or outer segment 3216can take a wide variety of different forms. For example, the round orouter segment 3216 can comprise a plurality of metal struts that formcells and form part of the frame 350 or be attached to the frame 350.The round or outer segment 3216 can be made of a foam material. FIG. 32illustrates one of many possible configurations.

In the example of FIG. 32, the retaining portion 314 forms a relativelywider inflow portion 2912. A relatively narrower portion 2916 forms theseat 18. A tapered portion 2918 joins the wider portion 2912 and theseat 18. The round or outer segment 3216 extends radially outward fromthe relatively narrower portion 2916.

In the example of FIG. 32, the frame 350 comprises a plurality of metalstruts 1200 that form cells 2904. In the example of FIG. 32, cells ofthe retaining portion 314 are uncovered. A covering/material 21 (e.g.,an impermeable material, semi-permeable material, material like thosediscussed above, etc.), such as a cloth or fabric or a protective foamcan be provided over the narrow portion 2916, the tapered portion 2918,and the round or outer segment 3216. The covering/material 21 thatextends to the frame 350 forms the sealing portion 310 of the dockingstation 10. The valve 29 expands in the narrow portion 2916 that formsthe valve seat 18.

The docking station can be made from a very resilient or compliantmaterial to accommodate large variations in the anatomy. For example,the docking station can be made from a highly flexible metal, metalalloy, polymer, or an open cell foam. An example of a highly resilientmetal is nitinol, but other metals and highly resilient or compliantnon-metal materials can be used. The docking station 10 can be selfexpandable, manually expandable (e.g., expandable via balloon),mechanically expandable, or a combination of these. A self-expandabledocking station 10 can be made of a shape memory material such as, forexample, nitinol.

Referring to FIG. 32, in one exemplary embodiment a band 20 extendsabout the waist or narrow portion 2916, or is integral to the waist toform an unexpandable or substantially unexpandable valve seat 18. Theband 20 can also extend over other portions of the docking station aswell. The band 20 stiffens the waist and, once the docking station isdeployed and expanded, makes the waist/valve seat relativelyunexpandable in its deployed configuration. In the example of FIG. 32,the valve 29 is secured by expansion of its collapsible frame into thevalve seat 18, of the docking station 10. The unexpandable orsubstantially unexpandable valve seat 18 prevents the radially outwardforce of the valve 29 from being transferred to the inside surface 416of the circulatory system. However in one exemplary embodiment, thewaist/valve seat of the deployed docking station can optionally expandslightly in an elastic fashion when the valve 29 is deployed against it.This optional elastic expansion of the waist 18 can put pressure on thevalve 29 to help hold the valve 29 in place within the docking station.

The band 20 can take a wide variety of different forms and can be madefrom a wide variety of different materials. The band 20 can be made ofPET, one or more sutures, fabric, metal, polymer, a biocompatible tape,or other relatively unexpandable materials known in the art that aresufficient to maintain the shape of the valve seat 18 and hold the valve29 in place. The band can extend about the exterior of the stent, or canbe an integral part of it, such as when fabric or another material isinterwoven into or through cells of the stent. The band 20 can benarrow, such as the suture band in FIG. 32, or can be wider. The bandcan be a variety of widths, lengths, and thicknesses. In onenon-limiting example, the valve seat 18 is between 27-28 mm wide,although the diameter of the valve seat should be within the operatingrange of the particular valve 29 that will be secured within the valveseat 18, and can be different than the foregoing example. The valve 29,when docked within the docking station, can optionally expand aroundeither side of the valve seat slightly, e.g., in an hourglass-likeshape.

FIG. 33 illustrates the docking station 10 of FIG. 32 implanted in thecirculatory system, such as in the inferior vena cava IVC. In FIG. 33,outer segment 3216, the narrow portion 2916 and/or the tapered portion2918 extend into the right atrium RA and the retaining portion 314 isheld in place in the inferior vena cava IVC. Any contact between theinterior surface of the right atrium RA and the docking station 10 iswith the outer segment 3216. The shape and atraumatic configuration ofthe outer segment 3216 protects the interior surface of the right atriumRA.

The sealing portion 310 provides a seal between the docking station 10and an interior surface 416 of the circulatory system, such as at thejunction between the inferior vena cava IVC and the right atrium. In theexample of FIG. 33, the sealing portion 310 is formed by providing thecovering/material 21 (which can be the same as or similar to othercoverings/materials described elsewhere herein) over the frame 350 or aportion thereof. In particular, the sealing portion 310 can comprise thenarrow portion 2916, the outer segment 3216, the tapered portion 2918and/or a covered portion of the retaining portion 314. In an exemplaryembodiment, the covering/material 21 covers the outer segment 3216, thenarrow portion 2916, the tapered portion 2918, and optionally a portionof the retaining portion 314. In one embodiment, the covering/materialcan be configured to encourage or enhance tissue ingrowth (e.g.,covering/material 21 can have a large surface area and/or be hydrophilicto enhance tissue ingrowth). This provides a seal and makes the dockingstation impermeable or substantially impermeable from the sealingportion 310 to the seal between the valve 29 and the docking station 10at the valve seat 18. As such, blood flowing in the inflow direction 12toward the outflow direction 14 is directed to the valve seat 18 (andvalve 29 once installed in the valve seat).

As one example, when the docking station 10 is placed in the inferiorvena cava IVC, which is a large vessel, the significant volume of bloodflowing through the vein is funneled into the valve 29 by the covering21. The covering 21 can be fluid impermeable or become fluid impermeable(e.g., via tissue ingrowth) so that blood cannot pass through. A varietyof biocompatible covering materials can be used such as any materialsdescribed elsewhere herein, including foam or a fabric that is treatedwith a coating that is impermeable to blood, polyester, or a processedbiological material, such as pericardium. More of the docking stationframe 350 can be provided with the covering/material 21, forming arelatively large impermeable portion.

FIGS. 34 and 35 illustrate an exemplary embodiment where the outersegment 3216 of the docking station 10 illustrated by FIG. 32 is formedas a portion of the frame 350. In the example of FIGS. 34 and 35, thevalve seat 18 is formed by inner struts 3400. The retaining portion 314is formed by lower struts 3410. The lower struts 3410 extendlongitudinally and radially outward from the inner struts 3400. Thelower struts 3410 terminate at a lower end 3412 of the docking station10. The outer segment 3216 is formed by top and outer struts 3520 thatextend radially outward 3450, and then downward 3452 and inward 3454.

In FIG. 35, the entire frame 350 is comprises a plurality of metalstruts 1200 that form cells 2904. In FIG. 32, cells of the retainingportion 314 are uncovered. A covering/material 21 (which can be the sameas or similar to coverings/materials 21 discussed previously), such as acloth or fabric or a protective foam can be provided at the valve seat18 (i.e. inside or outside the struts 1200), the round or outer segment3216 and part of the retaining portion 314. For example, referring toFIG. 35 all of the portion 3550 above the line 3530 can be covered andthe portion 3552 below the line 3530 can be uncovered. The line 3530 canbe adjusted to ensure that the material 21 extends to the area ofcontact with the inside surface 416 (e.g., to an area expected to be incontact with the inside surface 416 at the junction between the IVC andthe right atrium).

The docking station illustrated by FIGS. 34 and 35 can be made from avery resilient or compliant material to accommodate large variations inthe anatomy. For example, the docking station 10 can be made from ahighly flexible metal, metal alloy, polymer, or an open cell foam. Anexample of a highly resilient metal is nitinol, but other metals andhighly resilient or compliant non-metal materials can be used. Thedocking station 10 can be self expandable, manually expandable (e.g.,expandable via balloon), mechanically expandable, or a combination ofthese. A self-expandable docking station 10 can be made of a shapememory material such as nitinol.

FIG. 36 illustrates an exemplary embodiment of an expandable dockingstation 10 with a retaining portion 314 that is disposed in the inferiorvena cava IVC and a valve seat 18 that is disposed in the right atriumRA. The expandable docking station 10 includes one or more sealingportions 310, a valve seat 18, and one or more retaining portions 314.In FIG. 36, the docking station 10 is configured to provide a seal 3610at the atrium-vein junction 3612. The seal 3610 at the atrium-veinjunction 3612 can be provided in a variety of different ways. In FIG.36, the frame 350 transitions 3616 radially outward from the retainingportion 314 toward the end 3617 of the docking station 10 to form anenlarged portion or skirt 3618. The enlarged portion or skirt 3618 isflexible such that the portion of the docking station that makes contactwith a surface of the atrium is soft. The enlarged portion or skirt canalso be covered with a foam or other material to further soften thepotential areas of contact between the atrium and the docking station10.

A sealing portion 310 is configured to prevent or inhibit blood flowwhere the atrium-vein junction 3612 meets the enlarged portion or skirt3618 when implanted. An additional sealing portion 310′ is provided toprevent or inhibit blood from flowing between the valve 29 and dockingstation. In the example of FIG. 36, the additional sealing element 310′is disposed on the portion of the frame 350 that forms the valve seat 18and extends to the sealing element 310. As such, the two sealingelements 310, 310′ prevent or inhibit blood from flowing around theoutside of the transcatheter valve 29. In another exemplary embodiment,the sealing element 310 can cover the entire enlarged portion 3618 orskirt and extend into the area of the valve seat 18 to eliminate theneed for the second sealing element 310′.

The sealing portions can take a wide variety of different forms. In theexample of FIG. 36, a fabric, polymer, or other covering is attached toa portion of the frame 350 to form the sealing portion 310. However, thesealing portion 310 can be formed in a wide variety of other ways. Thesealing portion 310 can take any form that prevents or inhibits theblood from flowing around the outside surface of the valve 29 throughthe docking station frame.

The retaining portions 314 of the FIG. 36 embodiment can take a widevariety of different forms. For example, the retaining portion(s) 314can be any structure that sets the position of the docking station 10 inthe circulatory system and can be the same as or similar to retainingportion(s) 314 discussed elsewhere in this disclosure. For example, theretaining portion(s) 314 can press against or into the inside surface416 or extend around an anatomical structure of the circulatory systemto set the position of the docking station 10. The retaining portion(s)314 can be part of or define a portion of the body and/or sealingportion of the docking station 10 or the retaining portion(s) 314 can bea separate component that is attached to the body of the dockingstation. The docking station 10 can include a single retaining portion314, two of these, or more than two.

In FIG. 36, the retaining portion 314 comprises the annular outerportion or wall 368 of the frame 350. A shape set of annular outerportion or wall 368 biases the annular outer portion or wall 368radially outward and into contact with the interior surface 416 of thecirculatory system to retain the docking station 10 and the valve 29 atthe implantation position. The retaining portion 314 can be elongated toallow a small force to be applied to a large area of the interiorsurface 416. For example, the length of the retaining portion 314 can betwice, three times, four times, five times, or greater than five timesthe outside diameter of the transcatheter valve.

Referring to FIGS. 37-41, in one exemplary embodiment the frames 350used in the docking stations 10 include springs or spring/flexiblesegments 3700 to allow the frames 350 to bend. The spring/flexiblesegments 3700 allow the stent segments to anchor on the walls of theblood vessel while enabling the docking station to curve if needed. Inthe example of FIG. 37, frame or stent segments 3702 are attached toeach other by multiple springs or spring/flexible segments 3700. Any ofthe frames shown and described herein can optionally have anycombination of spring/flexible segments 3700 and frame or stent segments3702. The spring/flexible segments 3700 can take a wide variety ofdifferent forms. Examples of spring/flexible segments 3700 include,without limit, spring wires, springs constructed by selective removal ofmaterial (see FIG. 40) compression springs, torsion springs, and/ortension springs.

In FIG. 38, the spring/flexible segments 3700 allow the frame 350 tomore easily bend 3800. The frame 350 can bend in a wide variety ofdifferent ways. In the example of FIG. 38, springs on one side 3802stretch and springs on another side 3804 compress to bend 3800 in theindicated direction. Since multiple spring/flexible segments 3700 areprovided in the frame 350, the frame can easily bend in differentdirections along the length of the frame 350.

FIG. 39 illustrates that the frame or stent segments 3702 are expandable3900 and compressible 3902. By having separate frame or stent segments3702 connected by spring/flexible segments 3700, the frame can moreeasily conform to blood vessels that have varying sizes. The combinationof the frame or stent segments 3702 and spring segments allows the frameto conform to blood vessels that vary in cross-sectional size of thevessel, cross-sectional shape of the vessel, and the flow shape or pathof the vessel.

FIG. 40 illustrates an exemplary embodiment where the frame or stentsegments 3702 are integrally formed with the spring/flexible segments3700. For example, the frame or stent segments 3702 and thespring/flexible segments 3700 can be cut from a single piece ofmaterial, such as a shape memory alloy, such as nitinol. In theillustrated example, the stent segment 3702 comprises a matrix ofinterconnected struts 1200 that are joined to form cells 4000 withopenings 4002. However, the stent segments 3702 can be formed by a widevariety of different cutting patterns. The illustrated spring segments3700 are formed by cutting a strap/strut 4010 with notches 4012. But thespring/flexible segments 3700 can be formed with many different cuttingpatterns.

FIG. 41 illustrates an exemplary embodiment of a docking station 10 thatincludes two frame or stent segments 3702 connected by spring/flexiblesegments 3700. In the example of FIG. 41, the docking station 10 isdeployed in a blood vessel 4100 that is curved and has a varyingcross-sectional size. A first frame or stent segment 4110 expands 4112to a first size to conform to the size of the vessel 4100 at thelocation where the first frame or stent segment is deployed. A secondframe or stent segment 4120 expands 4122 to a second, larger size toconform to the size of the vessel 4100 at the location where the secondframe or stent segment is deployed. The vessel 4100 is curved from thelocation of the first stent or frame segment 4110 to the location of thesecond stent or frame segment 4120. The spring/flexible segments 3700allow the frame 350 to bend 4130 and conform to the curvature of thevessel 4100.

FIGS. 42-45 illustrate exemplary embodiments where two docking stations10 are connected together by a connecting portion 4250 to form a dualdocking station 4200. In the examples of FIGS. 42-45, the dual dockingstation 4200 is configured such that a first docking station 4210 can bedeployed in the inferior vena cava IVC and a second docking station 4212can be deployed in the superior vena cava SVC. The docking stations 4210and 4212 can be connected together in a wide variety of different ways.

The docking stations 4210, 4212 can take a wide variety of differentforms. For example, the docking stations 4210, 4212 can be any of thedocking stations 10 disclosed herein. In the examples of FIGS. 42-45,one of the docking stations 10 illustrated by FIGS. 12-19 and 20A-20Ccan be incorporated. The dockings stations 4210, 4212 can be the same orthe docking stations 4210, 4212 can be a different size and/or type.

In one exemplary embodiment, one of the ends is not provided with adocking station. For example, a docking station 4210 can be positionedin the inferior vena cava IVC and the connecting portion 4250 and/or andan expandable frame 4110 (See FIG. 41) extends into the superior venacava SVC to stabilize the docking station 4210, without acting as adocking station. Similarly, a docking station 4212 can be positioned inthe superior vena cava SVC and the connecting portion 4250 and/or and anexpandable frame 4110 (See FIG. 41) extends into the inferior vena cavaIVC to stabilize the docking station 4212, without acting as a dockingstation.

The connecting portion 4250 can take a wide variety of different forms.In one exemplary embodiment, the connecting portion 4250 is constructedto allow blood to freely flow through the connecting portion. Forexample, the connecting portion 4250 can be an open cell frame 4260 asillustrated by FIG. 42. The connecting portion 4250 can comprise springportions 3700 as illustrated by FIG. 43. The connecting portion 4250 cancomprise wires 4262 as illustrated by FIG. 44. In one embodiment, theconnecting portion 4250 comprises an open cell frame 4260, springportions 3700, and/or wires 4262. Referring to FIG. 45, in oneembodiment the connecting portion 4250 is configured to bend as itextends from the superior vena cava SVC to the inferior vena cava IVC.In the example of FIG. 45, the connecting portion 4250 is configured torest against an interior wall 450 of the right atrium RA. The connectingportion 4250 can be integrally formed with the docking stations 4210,4212 or the connecting portion can be made separately from one or bothof the docking stations 4210, 4212 and attached to the dockingstation(s).

In one embodiment, a docking station 10 can include sealing portions 310and/or retaining portions 314 or combined sealing and retaining portionsthat are radially expandable. The sealing portions 310 and/or retainingportions 314 can be configured to expand in a wide variety of differentways. In the example of FIGS. 46 and 47, combined radially expandablesealing and retaining portions 4610 comprise a material 4612, such as afabric, cloth, foam, etc., and a line or chord 4614. In FIG. 47, theline or chord 4614 is attached to the material 4612 such that pulling onthe line or cord 4614 causes the material 4612 to linearly retract,bunch or accordion, and thereby expand radially outward as shown. Thelines or cords 4614 are shown taut in FIG. 47 to represent pulling thelines or cords (e.g., pulling down on the lower line/cord 4614 in theIVC and pulling up on the upper line/cord 4614 in the SVC, but otherpulling directions/combinations are also possible) to axially contractand radially expand the material 4612. For example, a first end 4620 ofthe material 4612 can be attached to the frame 350. The line or cord4614 can be attached to a second end 4630. The line or chord 4614 can berepeatedly threaded back and forth through the material 4612 as itextends from the first end 4620 to the second end 4630. As such, thematerial is cinched up, with the length L retracted and radial thicknessT expanded.

Sealing portions 310 and/or retaining portions 314 or combined sealingand retaining portions that are radially expandable can be implementedon any docking station 10 disclosed herein. In the example of FIGS. 46and 47, the combined radially expandable sealing and retaining portions4610 are provided on a stent or frame 4660 to form a docking station.The radially expandable portions extend around the circumference of thestent or frame 4660. The stent or frame 4660 can take a wide variety ofdifferent forms. For example, the stent or frame can be any conventionalstent or frame or any of the frames 350 disclosed herein. In FIG. 46,the stent or frame 4660 is configured to extend from the superior venacava SVC to the inferior vena cava IVC. However, in some embodiments,the stent or frame 4660 can be configured to engage and seal with onlyone inner surface area. The stent or frame 4660 can be configured toengage and seal with one or more interior surface areas of the heart H.For example, a stent or frame 4660 with one or more radially expandableportions 4610 can be configured to be deployed and act as a valve seat18 in the inferior vena cava IVC, the superior vena cava SVC, the aorta,the pulmonary artery, the aortic valve AV, the mitral valve MV, thepulmonary valve PV, or the tricuspid valve TV.

The stent or frame 4660 can take a wide variety of different forms. Inthe example of FIGS. 46 and 47, the stent or frame 4660 is disposed inthe right atrium RA. In one embodiment, the stent or frame 4660 or theportion of the stent or frame 4660 in the right atrium has and openconfiguration to allow blood in the atrium to easily flow through thestent or frame 4660. For example, the stent or frame 4660 can take anyof the forms illustrated by FIGS. 42-44.

The docking station profile illustrated by FIG. 48 is taken from U.S.patent application Ser. No. 15/422,354, titled “Docking Station for aTranscatheter Heart Valve,” filed on Feb. 1, 2017 and published as US2017/0231756, which claims priority to provisional application No.62/292,142, filed on Feb. 5, 2016. These application are incorporatedherein by reference in their entireties. Any concepts, aspects, featuresor other materials disclosed by these applications can be used incombination with any of the embodiments disclosed in this application,e.g., docking station 10 illustrated by FIG. 48 can be configured to bedeployed in the aorta, IVC, and/or SVC.

FIG. 49 illustrates an exemplary embodiment of a docking station 10 thatis similar to the docking station illustrated by FIG. 48, except theradially outwardly extending ends 4800 are replaced with ends 4900 thatdo not extend radially outward. For example, the ends 4900 can extendaxially as illustrated or can extend radially inward.

FIG. 50 illustrates an exemplary embodiment where the docking station 10illustrated by FIG. 48 or 49 is deployed in the circulatory system, suchas in the inferior vena cava IVC. In the example illustrated by FIG. 50,the entire docking station is held in place in the inferior vena cavaIVC by the frame 350. The sealing portion 310 provides a seal betweenthe docking station 10 and an interior surface 416 of the circulatorysystem, such as at the junction between the inferior vena cava IVC andthe right atrium.

In the example of FIG. 50, the sealing portion(s) 310 are formed byproviding a covering/material over the frame 350 or a portion thereof.Referring to FIGS. 48 and 49, the sealing portion(s) 310 can comprisethe narrow portion 4916, one or both of the tapered portions 4918 and/orthe retaining portion 314. In an exemplary embodiment, acovering/material (which can be the same as or similar to othercoverings/materials described elsewhere herein) covers the narrowportion 4916, the tapered portion 4918, and a portion of the retainingportion 314. In one embodiment, the covering/material can be configuredto encourage or enhance tissue ingrowth (e.g., covering/material canhave a large surface area and/or be hydrophilic to enhance tissueingrowth). This makes the docking station impermeable or substantiallyimpermeable from the sealing portion 310 to the seal between the valve29 and the docking station 10 at the valve seat 18. As such, bloodflowing in the inflow direction 12 toward the outflow direction 14 isdirected to the valve seat 18 (and valve 29 once installed or deployedin the valve seat).

As one non-limiting example, when the docking station 10 is placed inthe inferior vena cava IVC, which is a large vessel, the significantvolume of blood flowing through the vein is funneled into the valve 29by a covering/material. The covering/material can be fluid impermeableor become fluid impermeable (e.g., via tissue ingrowth) so that bloodcannot pass through. Again, a variety of other biocompatible coveringmaterials can be used such as any materials described elsewhere herein,including, for example, foam or a fabric that is treated with a coatingthat is impermeable to blood, polyester, or a processed biologicalmaterial, such as pericardium. More or all of the docking station frame350 can be provided with the covering/material, forming a relativelylarge impermeable portion.

FIG. 51 illustrates an exemplary embodiment of a docking station frame350 constructed from a coil 5100 of material. The coil 5100 can take awide variety of different forms and FIG. 51 illustrates just one of themany possible configurations. In the example of FIG. 51, the retainingportion 314 comprises two relatively larger diameter coil segments 5110and a smaller diameter segment 5112 that forms the valve seat 18.However, in other exemplary embodiments, only a single larger diametercoil segment 5110 may be included. Transition coil segments 5114 jointhe smaller diameter segment 5112 to the larger diameter segment 5112.

A covering/material (not shown), such as one of the coverings/materialsdescribed elsewhere herein, a cloth, fabric, or a protective foam can beprovided inside or outside the coil to provide a sealing portion to thecoil 5100 and create a sealing docking station. Such a covering/materialcan be connected to the coil or can be deployed separately from the coil5100 (e.g., deployed either before or after deployment of the coil 5100)and/or with the transcatheter valve 29. The valve 29 expands and isimplanted in the smaller diameter segment 5112, which forms the valveseat 18.

The docking station coil 5100 can be made from a very resilient orcompliant material to accommodate large variations in the anatomy. Forexample, the docking station coil 5100 can be made from a highlyflexible metal, metal alloy, or polymer. An example of a highlyresilient metal is nitinol, but other metals and highly resilient orcompliant non-metal materials can be used. The docking station 10 can beself expandable, manually expandable (e.g., expandable via balloon),mechanically expandable, or a combination of these. A self-expandabledocking station 10 can be made of a shape memory material such as, forexample, nitinol.

FIG. 52 illustrates the docking station coil 5100 of FIG. 51 implantedin the circulatory system, such as in the inferior vena cava IVC. In theexample of FIG. 52, the coil is held in place in the inferior vena cavaIVC by a lower larger diameter segment 5110. An upper larger diametersegment 5110 is disposed in the right atrium RA. The larger diametersegment 5110 can expand to a larger size in the right atrium asillustrated, the larger diameter segments can expand to the same size,or the larger diameter segment in the IVC can expand to a larger sizethan the larger diameter segment in the right atrium RA. Sealingportion(s) 310 can be formed by providing the covering/material 21(which can be the same as or similar to other coverings/materialsdescribed herein) over or inside the frame 350 or a portion thereof. Inan exemplary embodiment, covering/material 21 covers the smallerdiameter segment 5112 and one or both of the larger diameter segments5110. This can make a docking station 10 that includes the coil 5100impermeable or substantially impermeable from the sealing portion 310 tothe seal between the valve 29 and the docking station 10 at the valveseat 18. As such, blood flowing in the inflow direction 12 toward theoutflow direction 14 is directed to the valve seat 18 (and valve 29 onceinstalled or deployed in the valve seat).

As one non-limiting example, when the docking station 10 is placed inthe inferior vena cava IVC, which is a large vessel, the significantvolume of blood flowing through the vein is funneled into the valve 29by a covering or inner layer. The covering can be fluid impermeable orsubstantially impermeable so that blood or most blood cannot passthrough. Again, a variety of other biocompatible covering materials canbe used such as any materials described elsewhere herein, including, forexample, foam or a fabric that is treated with a coating that isimpermeable to blood, polyester, or a processed biological material,such as pericardium. More or all of the docking station frame 350 can beprovided with the covering/material (e.g., an impermeablecovering/material), forming a relatively large impermeable portion.

FIGS. 53 and 54 illustrate exemplary embodiments of a docking station10. The frame 350 or body can take a wide variety of different forms andFIG. 53 illustrates just one of the many possible configurations. Arelatively narrower/smaller diameter portion 5316 forms the seat 18. Therelatively narrow portion 5316 can take a wide variety of differentforms. For example, the narrow portion 5316 can be any of the valveseats 18 disclosed herein, a ring, any conventional stent or frame, etc.In one exemplary embodiment, the inner ends 5380 themselves act as thevalve seat 18. In one exemplary embodiment, the narrow portion 5316 isreplaced with a valve/THV 29, e.g., the valve is integrated with thedocking station structure such that the entire assembly acts as atranscatheter valve and can be implanted as one in the same implantationstep.

Referring to FIGS. 53 and 54, spaced apart radially outwardly extendingarms 5318 disposed around a perimeter of the narrow portion 5316 formthe retaining portion 314. In the example of FIG. 53, inner ends 5380 ofthe arms 5318 are connected to each other, are positioned adjacent toone another, or are spaced apart, but positioned close to one another.The example illustrated by FIG. 54 is substantially the same as theexample of FIG. 53, except the inner ends 5380 of the arms 5318 areconnected to ends 5381 of the narrow portion 5316. The docking stationcan include a variety of combinations and arrangements of arms 5318, andcan include 2-32 arms (e.g., 2-16 arms) or more arms.

The radially outwardly extending arms 5318 can take a wide variety ofdifferent forms. In the illustrated example, the arms 5318 compriseupper arms 5328 and lower arms 5338. The docking station can comprise1-16 upper arms 5328 (e.g., 1-8 upper arms) or more and can be radiallyspaced apart evenly or unevenly, and can comprise 1-10 lower arms 5338(e.g., 1-8 lower arms) or more and can be radially spaced apart evenlyor unevenly. In one exemplary the upper arms 5328 are coupled to thelower arms 5338 and/or the inner portion 5316 such that the upper andlower arms 5328, 5338 are moveable relatively toward and away from oneanother.

Referring to FIGS. 55A-55C, moving the upper arms 5328 and lower arms5338 relatively toward and away from one another increases and decreasesthe diameter D or width of the docking station 10. For example, FIG. 55Bcan correspond to a nominal position, such as an average size of animplantation site (e.g., vessel, annulus, etc.) that the docking stationwill be deployed in. However, any size can be selected. FIG. 55Aillustrates that moving 5592 the arms 5328, 5338 relatively toward oneanother increases 5593 the diameter D or width of the docking station.That is, the arms 5328 extend more in the radial direction 5593 and lessin the axial direction 5592 (as compared to FIG. 55B) and the width ordiameter D increases. FIG. 55C illustrates that moving 5594 the arms5328, 5338 relatively away from one another decreases the diameter D (ascompared to FIG. 55B) or width of the docking station 10. That is, thearms 5328, 5338 extend less in the radial direction 5595 and more in theaxial direction 5594 and the width or diameter D of the docking stationdecreases.

The arms 5328, 5338 can be moved relatively toward and away from oneanother in a wide variety of different ways. For example, the arms 5328,5338 can be made from a shape memory alloy with the shape set to theclosest spacing between the arms 5328, 5338 (i.e. the largest diameter).Or, a spring can be provided between the arms 5328, 5338 to bias thearms to a desired spacing. When the arms 5328, 5338 are biased to thelargest diameter, the docking station 10 will deploy until the armsengage an inside surface 416 (e.g., vessel walls, IVC walls, SVC walls,aorta walls, an annulus of a native heart valve, tissue surrounding anannulus of a native heart valve, leaflets, etc.) with enough force tostop expanding and to securely hold the docking station in place.

In one exemplary embodiment, the distance between the arms 5328 and thusthe diameter D or width can be adjusted manually. The distance betweenthe arms 5328 and thus the diameter D or width can be adjusted manuallyin a wide variety of different ways. For example, the arms 5328, 5338can be biased to a first position and an adjustment cord, line or wire5370 is coupled to the arms 5328, 5338 to move the arms from the firstposition. The arms 5328, 5338 can be biased to a first position in awide variety of different ways. For example, the arms 5328, 5338 can bemade from a shape memory alloy with a shape set or the arms can becoupled with a spring, etc. The shape set or spring, etc. can be set tomake the spacing between the arms 5328 and the corresponding arms 5338as great as possible, such as a 180 degree angle or approximately 180degree angle (e.g., ±10 degrees, ±5 degrees) defined between (i.e.extending directly apart in the axial direction). When the arms 5328 andthe arms 5338 are biased very far apart, the docking station 10 can beinitially deployed in a very narrow configuration. In the narrowconfiguration, the docking station 10 can be moved to a selected finaldeployment site and proper positioning can be checked. Once properlypositioned, the diameter D or width can be adjusted with the adjustmentcord, line or wire 5370. For example, the cord, line or wire 5370 can bepulled to reduce the spacing between the arms 5328 and the arms 5338 andthereby increase the diameter D or width of the docking station 10 andthe strength of engagement with inner surface 416 (e.g., vessel walls,IVC walls, SVC walls, aorta walls, an annulus of a native heart valve,tissue surrounding an annulus of a native heart valve, leaflets, etc.).Once the docking station 10 is properly, securely engaged with the innersurface 416, the position of the arms 5328, 5338 can be secured tosecure the docking station in place. In some embodiments, the shape setor spring, etc. can be set to make the spacing between the arms 5328 andthe corresponding arms 5338 as small as possible, such as touching eachother or with 5, 10, 20, 30 degrees or less defined between (i.e. thearms all extending in the radial or generally radial direction).

In another exemplary embodiment, the distance between the arms 5328 andthus the diameter D or width can be adjusted manually to both increasethe diameter D or width and decrease the diameter or width. For example,adjustment cords, lines or wires 5370 are coupled to the arms 5328, 5338such that they can both move the arms toward each other and away fromeach other. The spacing between the arms 5328, 5338 can be as great aspossible during initial deployment, such as a 180 degree angle orapproximately 180 degree angle defined between (i.e. extending directlyapart in the axial direction). In the narrow configuration, the dockingstation 10 can be moved to a selected final deployment site and properpositioning can be checked. Once properly positioned, the diameter D orwidth can be adjusted with the adjustment cord, line or wire 5370. Forexample, the cord, line or wire 5370 can be pulled to reduce the spacingbetween the arms 5328, 5338 and thereby increase the diameter D or widthof the docking station 10 and the strength of engagement with innersurface 416 (e.g., vessel walls, IVC walls, SVC walls, aorta walls, anannulus of a native heart valve, tissue surrounding an annulus of anative heart valve, leaflets, etc.). Once the docking station 10 isproperly, securely engaged with the inner surface 416, the position ofthe arms 5328, 5338 can be secured to secure the docking station inplace.

In the example of FIGS. 53 and 54, the sealing portion 310 comprises acovering/material 21 (which can be the same as or similar to othercoverings/materials described elsewhere herein), such as a cloth orfabric or a protective foam provided on the arms 5328, the arms 5338, orboth sets of arms 5328, 5338. The covering/material (e.g., animpermeable material or semi-permeable material) can extend from theinner ends 5380 and valve seat 18 to outer ends 5390 of the arms 5328and/or 5338 to form the sealing portion 310 of the docking station 10.The valve 29 can expand and be implanted in the narrow portion 5316,which forms the valve seat 18. It should be understood that thecovering/material can extend three-dimensionally to create a sealingregion circumferentially around the valve 29 when deployed in thecirculatory system. For example, the covering/material can have aconical shape, frustoconical shape, funnel shape, other shape, etc. thatcan guide blood flow to the valve 29 and inhibit or prevent paravalvularleakage.

The docking stations 10 illustrated by FIGS. 53 and 54 can be made froma very resilient or compliant material to accommodate large variationsin the anatomy. For example, the docking station can be made from ahighly flexible metal, metal alloy, polymer, or an open cell foam. Anexample of a highly resilient metal is nitinol, but other metals andhighly resilient or compliant non-metal materials can be used. Thedocking station 10 can be self expandable, manually expandable,mechanically expandable, or a combination of these. A self-expandabledocking station 10 can be made of a shape memory material such as, forexample, nitinol.

FIG. 56 illustrates the docking station 10 of FIG. 53 or 54 implanted inthe circulatory system, such as in the inferior vena cava. In FIG. 56,the entire docking station is held in place in the inferior vena cava bythe arms 5328, 5338. The covering/material 21 of the sealing portion 310can make docking station 10 impermeable or substantially impermeablefrom the sealing portion 310 to the seal between the valve 29 and thedocking station 10 at the valve seat 18. As such, blood flowing in theinflow direction 12 toward the outflow direction 14 flows through thevalve seat 18 (and valve 29 once installed or deployed in the valveseat).

As one non-limiting example, when the docking station 10 is placed inthe inferior vena cava IVC, which is a large vessel, the significantvolume of blood flowing through the vein is funneled into the valve 29by the covering or inner layer. The covering can be fluid impermeable orsubstantially impermeable so that blood cannot pass through. Again, avariety of other biocompatible covering materials can be used such asany materials described elsewhere herein, including, for example, foamor a fabric that is treated with a coating that is impermeable to blood,polyester, or a processed biological material, such as pericardium.

In some exemplary embodiments, the wall 368 of the frame 350 of thedocking station can have a non-circular shape or non-circular radialcross-section. A wide variety of different non-circular shapes can beimplemented. FIG. 57 illustrates one example of a docking station 10having a frame 350 with a non-circular shape or non-circular radialcross-section. In this example, the expandable docking station 10includes one or more sealing portions 310, a valve seat 18, and one ormore retaining portions 314. In an alternate embodiment, the dockingstation 10 and the valve 29 can be integrally formed, such that thecombination forms a transcatheter valve that can be implanted as one inthe same implantation step.

In the example of FIG. 57, the non-circular shape of the frame 350allows an axially extending frame with a constant shape or cross sectionalong its length (prior to engagement by an inner surface 416) to bothengage the interior surface 416 of the circulatory system and provide aseat 18 for the valve 29. The frame 350 with a constant axial shape canbe configured to provide a valve seat 18 and an outer engagement surface5710 in a wide variety of different ways. In the example of FIG. 57, theframe 350 has an undulating perimeter 5712 with alternating innerportions 5714 and outer portions 5716. The frame 350 can consist only ofa wall 368 having the undulating configuration. However, the frame 350can have additional structures, such as a band or other reinforcementfor constraining the size of the valve seat 18.

The inner and outer portions 5714, 5716 can have a wide variety ofdifferent shapes and there can be any number of inner portions 5714 andouter portions 5716. For example, the inner and outer portions 5714,5716 can be formed by any series of lines and/or curves. In theillustrated embodiment, the frame 350 has four outer portions 5714 andfour inner portions 5716, but the frame can have any number of innerportions and outer portions. For example, the frame 350 can have anynumber of inner portions and outer portions 5714, 5716 in the range from3 to 100.

In the example of FIG. 57, the inner portions 5714 comprise concavecurves and the outer portions 5716 comprise convex curves. The concavecurves and the convex curves are connected together to form a petalshape. However, the inner portions 5714 and the outer portions can formany shape. For example, increasing the number of inner portions 5714 andouter portions 5716 increases a number of points of contact between theframe 350 and inside surface 416 of the circulatory system and thenumber of points of contact between the frame 350 and the valve 29.

The expandable frame 350 can take a wide variety of different forms. Inthe illustrated example, the expandable frame 350 is an expandablelattice. The expandable lattice can be made from individual wires or canbe cut from a sheet and then rolled or otherwise formed into the shapeof the expandable frame. The frame 350 can be made from a highlyflexible metal, metal alloy, or polymer. Examples of metals and metalalloys that can be used include, but are not limited to, nitinol andother shape memory alloys, elgiloy, and stainless steel, but othermetals and highly resilient or compliant non-metal materials can be usedto make the frame 350. These materials can allow the frame to becompressed to a small size, and then when the compression force isreleased, the frame will self-expand back to its pre-compressed diameterand/or the frame can be expanded by inflation of a device positionedinside the frame.

The sealing portions 310 of the docking station 10 illustrated by FIG.57 can take a wide variety of different forms. A covering/material(which can be the same as or similar to other coverings/materialsdescribed elsewhere herein) can be attached to a portion of the frame350 to form the sealing portion 310. For example, the covering/materialcan cover an end 3762 as illustrated. In one embodiment, thecovering/material can cover (e.g., extend over or fill) the gaps orportions of the gaps between the inner portions 5714 and outer portions5716. Optionally, the covering/material can extend along the frame wall368. A portion of the frame wall 368 or the entire frame wall can becovered with the covering/material. However, the sealing portion 310 canalso be formed in a wide variety of other ways.

In the example of FIG. 57, the retaining portion 314 comprises the wall368 of the frame 350. A shape set of the wall 368 biases the outerportions 5716 radially outward and into contact with the interiorsurface 416 (See FIG. 2) of the circulatory system to retain the dockingstation 10 and the valve 29 at the implantation position. In theillustrated embodiment, the retaining portion 314 is elongated to allowa small force to be applied to a large area of the interior surface 416,which can allow the docking station to be securely held in place withoutexerting too much radial force on or damaging the interior surface 416.For example, the length of the retaining portion 314 can be twice, threetimes, four times, five times, or greater than five times the outsidediameter of the transcatheter valve.

FIG. 58 illustrates the docking station 10 of FIG. 58 implanted in thecirculatory system, such as in the inferior vena cava IVC. In theexample of FIG. 58, the entire docking station is positioned in theinferior vena cava IVC and held in place by the frame 350 pressingagainst the inner surface 416. As mentioned above, the docking station10 can be adapted for use at a variety of different positions in thecirculatory system.

FIGS. 59A and 59B illustrate an exemplary embodiment of a dockingstation frame 350 constructed from one or more coils 5900 of materialthat are formed into one or more rings 5902. The coil 5900 can take awide variety of different forms and FIGS. 59A and 59B illustrates justone of the many possible configurations. In the example of FIGS. 59A and59B, the coil 5900 is rotated 90 degrees compared to the coil 5100illustrated by FIG. 51, and is formed into a ring shape, whereas thecoil 5100 is not. The ring(s) 5902 can be formed by bending one or morewires into a coiled configuration and then wrapping or bending the coilaround an axis A of the docking station frame 350. The docking stationcan transition between a collapsed configuration (e.g., for easier,lower-profile delivery to an implantation site) and an expandedconfiguration (e.g., for securing the docking station in theimplantation site and allowing a transcatheter valve to be deployedtherein). FIG. 59A shows the docking station transitioning from acollapsed configuration to an expanded configuration. FIG. 59B shows thedocking station in an expanded configuration. The interior surface ofthe coil 5900 can act as the valve seat for receiving the transcathetervalve. The docking station and coil 5900 can be formed from any of thematerials described as being used to form other frame bodies 350elsewhere herein, including nitinol or another shape memory material.

The coil 5900 can be used to form a docking station 10 in a wide varietyof different ways. A valve seat 18 can be formed inside or attached tocoil 5900 illustrated by FIGS. 59A and 59B. Referring to FIG. 59C, inanother exemplary embodiment, a docking station 10 is formed from threecoils 5900 or coil portions. The coils 5900 can be integrally formed,for example, from a single wire or three separate coils 5900 can beconnected or linked together to form a docking station 10. In theexample of FIG. 59C, the docking station 10 comprises two relativelylarger diameter coil rings 5910 and a smaller diameter coil ring 5912that forms the valve seat 18. However, in some embodiments, only asingle larger diameter coil ring 5910 is included.

A covering/material 21 (See e.g., FIG. 59D), such as a cloth or fabricor a protective foam can be provided inside and/or outside the coil(s)5900 (e.g., the coil(s) shown in any of FIGS. 59A-59D) or a portion ofthe coil(s) to provide a sealing portion to the coil(s) 5900 and/or oneor more coil rings 5902, 5910, 5912, and create a sealed dockingstation. Such a covering/material can be connected to one or more of therings 5902, 5910, 5912 or can be deployed separately from the coil rings(e.g., deployed either before or after deployment of the coil(s) 5900)and/or with the valve/THV 29. The valve 29 (not shown in FIGS. 59A-59D)can expand in the center of coil 5900 of FIGS. 59A-59B or can expand inthe smaller coil ring 5912 of FIGS. 59C-59D, which forms the valve seat18.

The docking station coil(s) 5900 and coil ring(s) 5902, 5910, 5912 canbe made from a very resilient or compliant material to accommodate largevariations in the anatomy or any of the materials described elsewherewith respect to the various frame bodies 350 herein. For example, thedocking station coil(s) 5900 and coil ring(s) 5902, 5910, 5912 can bemade from a highly flexible metal, metal alloy, or polymer. An exampleof a highly resilient metal is nitinol, but other metals and highlyresilient or compliant non-metal materials can be used. The dockingstation 10 can be self expandable, manually expandable (e.g., expandablevia balloon), mechanically expandable, or a combination of these.

FIG. 59D illustrates the docking station 10 of FIG. 59C implanted in thecirculatory system, such as in the inferior vena cava IVC. In theexample of FIG. 59D, the docking station 10 is held in place in theinferior vena cava IVC by a lower larger diameter ring 5910. An upperlarger diameter segment 5910 is disposed in the right atrium RA. Thelarger diameter ring 5910 may expand to a larger size in the rightatrium than the ring in the IVC as illustrated, the larger diameter ringin the atrium and IVC may expand to the same size, or the largerdiameter ring in the IVC may expand to a larger size than the largerdiameter ring in the right atrium RA. Sealing portion(s) 310 can beformed by providing the covering/material 21 over or inside one or moreof the coil(s) 5900 and coil ring(s) 5902, 5910, 5912 or a portionthereof. In one embodiment, covering/material 21 covers the smallerdiameter ring 5912 and one or both of the larger diameter rings 5110.This can make docking station 10 impermeable or substantiallyimpermeable from the sealing portion 310 to the seal between the valve29 and the docking station 10 at the valve seat 18. As such, bloodflowing in the inflow direction 12 toward the outflow direction 14 isdirected to the valve seat 18 (and valve 29 once installed or deployedin the valve seat).

FIGS. 60A-60J illustrate exemplary embodiments that are similar to theembodiment illustrated by FIGS. 3A-3C, except the free ends of the frame350 are connected together and/or extend closer together. For example,an end 6000 of the valve seat 18 or inner ring is connected to an end6002 of the frame 350/outer wall 368 and/or is extended to or toward theend 6002 of the frame 350/outer wall 368. The end 6000 of the valve seat18 or inner ring can be connected and/or extended to or toward an end6002 of the frame 350 in a wide variety of different ways. FIGS. 60A-60Jillustrate a few of the possible ways that the end 6000 of the valveseat 18 or inner ring can be connected and/or extended to or toward anend 6002 of the frame 350.

Connecting the end 6000 of the valve seat 18 or inner ring to the end6002 of the frame 350 or extending the end 6000 of the valve seat 18 orinner ring to the end 6002 of the frame 350 can provide a number ofadvantages. For example, the docking station 10 can be more easilyloaded in the delivery catheter/sheath, and the docking station 10 canbe more easily recaptured or pulled back into the catheter/sheath ifinitial placement of the docking station is incorrect, imperfect, or ifthe medical professional wants to abort or redo the procedure for anyreason. Having the bottom/proximal end 6000 of the valve seat 18 coupledto the end 6002 of the frame can help urge the end 6000 of the valveseat 18 radially inwardly and into the catheter/sheath. As can be seen,for example, in FIGS. 21A-21H, the bottom/proximal end of the valve seat18 (identified in these Figures as end 2122) tends to extend outwardlyeven after the outer wall 368 begins to be compressed radially inwardly.During recapture, the end 6002 and/or proximal portion of the frame canbe first captured and/or retracted further into the deliverycatheter/sheath and, by having the bottom/proximal of the valve seat 18connected to the end 6002 of the frame, the retraction and compressionof end 6002 and the connections and/or portions of the frame proximal tothe valve seat 18 can help urge the bottom/proximal end of the valveseat 18 radially inwardly and into the delivery catheter/sheath. Thiscan also beneficially result in more gradual compression of the valveseat 18. Even if the ends are not connected, but end 6000 merely extendsto a location proximate end 6002 (e.g., such that the valve seat orinner ring or an extension therefrom has a similar length to the outerwall 368), this can help with loading, recapture, etc. For example, thelonger end or extensions from the valve seat can remain in thecatheter/sheath during partial deployment and allow for smootherrecapture of the partially deployed docking station. Also, the longerend/extension could help the transition into the catheter/sheath to bemore gradual and controlled.

Similarly, the valve seat 18 or ring of the docking station 10 can bemore uniformly compressed during the crimping process. For example, thecompression of the outer wall 368 before the outer wall 368 contacts thevalve seat 18 can aid or cause compression of both the proximal anddistal ends of the valve seat 18 or inner ring.

Another advantage of connecting the free ends of the frame 350 togetheror connecting end 6000 and end 6002 (and/or having the free ends extendcloser together) is that it can improve deployment of the dockingstation and make deployment more controlled. If not connected (or wherethe unconnected ends are not similarly located/extended or of similarlengths), the docking station can tend to jump or move unpredictably outof the delivery catheter/sheath when the free end (e.g., end 2122 shownin FIGS. 21A-21H) of the valve seat is released from the deliverycatheter/sheath. When no longer constrained by the deliverycatheter/sheath, the free end (e.g., end 2122) can expand suddenly andcause the docking station to jump or move. By connecting the free endsof the docking station frame together or connecting end 6000 and end6002 (and/or by extending the end of the valve seat closer to the end ofthe outer wall), the expansion of end 6000 can be more restrained andcontrolled as it is released from the delivery catheter/sheath such thatthe docking station deployment is more controlled and less likely tojump, move at all, or as much, i.e., it can prevent or inhibit/restrainjumping or uncontrolled movement of the docking station.

In the example of FIGS. 60A (cross-sectional side view) and 60B (top endview), the end 6000 of the valve seat 18 or inner ring is connected toan end 6002 of the frame 350 by one or more lines 6010. The line(s) 6010can take a wide variety of different forms. For example, the line(s)6010 can be a suture(s), a wire(s), rod(s), arm(s), strut(s), or anyother elongated member, and can be rigid, semi-rigid, or flexible. Inone embodiment, instead of a line(s), a covering/material (e.g., similarto the coverings/materials 21 described elsewhere herein) extends fromend 6000 to 6002 (e.g., in a conical or frustoconical shape).

In the example of FIGS. 60C (cross-sectional side view) and 60D (top endview), the end 6000 of the valve seat 18 or inner ring includes anintegral extension 6020 that extends to the end 6002 of the frame 350.In the illustrated embodiment, the extension 6020 is connected to theend 6002 of the frame 350. In another exemplary embodiment, theextension 6020 is in substantially the same position as illustrated byFIG. 60C, but the extension 6020 is not connected to the frame. Theextension can take a wide variety of different forms. In one exemplaryembodiment, a bottom row of cells of the valve seat 18 or inner ring iselongated and extends (e.g., has apices that extend) to the end 6002 ofthe frame 350. In one exemplary embodiment, the lattice of struts andcells forming the frame body can continue to form the extension 6020.

In the example of FIGS. 60E (cross-sectional side view) and 60F (top endview), the end 6000 of the valve seat 18 or inner ring includes anintegral extension 6030 that is substantially parallel to the outer wall368 in cross-section when expanded and extends to a location/lengthsimilar to outer wall 368. In the example of FIGS. 60E and 60F, theextension 6030 is not connected to the end 6002 of the frame 350. In theexample of FIG. 60G (cross-sectional side view) and 60H (top end view),the extension 6030 is in substantially the same position as of FIG. 60E,but the extension 6030 is connected to the frame by a connecting portion6040. The extension 6030 can take a wide variety of different forms. Inone exemplary embodiment, a bottom row of cells of the valve seat 18 orinner ring is elongated and extends (e.g., has apices that extend) asshown. The optional connecting portion 6040 can take a wide variety ofdifferent forms. For example, the connecting portion 6040 can compriseone or more line(s), such as a wire(s), suture(s), rod(s), arm(s),strut(s), and/or a covering/material 21.

In the example of FIGS. 60I (cross-sectional side view) and 60J (top endview), the frame 350 and seat 18 are integrally formed and can have atoroidal shape. Referring to FIG. 60I, in cross-section the frame 350and valve seat 18 form a loop or loops 6050. In one exemplaryembodiment, the loop 6050 is formed of a continuous lattice of strutsand cells. However, the loop(s) can be formed in a wide variety ofdifferent ways.

In various figures herein, a “V” or generic valve symbol is used torepresent generically a variety of valves that can have differentstructures for closing/opening the valve and can operate in differentways. FIGS. 61-65 illustrate a few examples of the many valves or valveconfigurations that can be used. Any valve type can be used and somevalves that are traditionally applied surgically can be modified fortranscatheter implantation. A transcatheter valve can be expanded in avariety of ways, e.g., it can be self expanding, expanded with aballoon, mechanically-expandable, and/or a combination of these. In oneexample, a mechanical opening mechanism, such as a hinged mechanism canbe used to expand the transcatheter valve and/or a frame of thetranscatheter valve can comprise a hinged mechanism. FIG. 61 illustratesan expandable valve 29 for transcatheter implantation that is shown anddescribed in U.S. Pat. No. 8,002,825, which is incorporated herein byreference in its entirety. An example of a tri-leaflet valve is shownand described in Published Patent Cooperation Treaty Application No. WO2000/42950, which is incorporated herein by reference in its entirety.Another example of a tri-leaflet valve is shown and described in U.S.Pat. No. 5,928,281, which is incorporated herein by reference in itsentirety. Another example of a tri-leaflet valve is shown and describedin U.S. Pat. No. 6,558,418, which is incorporated herein by reference inits entirety. FIGS. 62-64 illustrate an exemplary embodiment of anexpandable tri-leaflet valve 29, such as the Edwards SAPIENTranscatheter Heart Valve. The valve 29 can comprise a frame 712 thatcontains a tri-leaflet valve 4500 compressed inside the frame 712. FIG.63 illustrates the frame 712 expanded and the valve 29 in an opencondition. FIG. 64 illustrates the frame 712 expanded and the valve 29in a closed condition. FIGS. 65A, 65B, and 65C illustrate an example ofan expandable valve 29 that is shown and described in U.S. Pat. No.6,540,782, which is incorporated herein by reference in its entirety.Another example of a valve is shown and described in U.S. Pat. No.3,365,728, which is incorporated herein by reference in its entirety.Another example of a valve is shown and described in U.S. Pat. No.3,824,629, which is incorporated herein by reference in its entirety.Another example of a valve is shown and described in U.S. Pat. No.5,814,099, which is incorporated herein by reference in its entirety.Any of these, the valves described in the incorporated references, orother valves can be used as valve 29 in the various embodiments herein.

The docking stations described above can be used to form a dockingstation assembly, e.g., including a graft or other elements. Forexample, a docking station assembly can include a graft and a dockingstation. The graft can be shaped to conform to a portion of an interiorshape of a first portion of a circulatory system (e.g., of a bloodvessel, vasculature, native heart valve, etc.). The docking station andthe graft can be coupled to each other. The various docking stationsdescribed herein can be used in the assembly and can include anexpandable frame, at least one sealing portion, and a valve seat asdiscussed above. The expandable frame can be configured to conform to aninterior shape of a second portion of the circulatory system (e.g., of ablood vessel, vasculature, native heart valve, etc.) when expandedinside the circulatory system. The sealing portion can be configured tocontact an interior surface of the circulatory system. The valve seatcan be connected to the expandable frame. The valve seat can beconfigured to support an expandable transcatheter valve. The dockingstation can be integrally formed with a valve, e.g., such that thedocking station and valve combination is a prosthetic valve ortranscatheter prosthetic valve that can be implanted in the same step.The frame can be formed and configured in any of the ways described inthis disclosure, for example, the frame can be made of nitinol, elgiloy,or stainless steel. A portion of the docking station can engage aninterior of the graft. The graft can be shaped or configured to fit aninterior surface of the circulatory system.

Referring to FIGS. 66A through 72C, exemplary docking station deploymentassemblies/systems 7000 for deploying a docking station/device aredepicted. The various docking station deployment assemblies/systems 7000herein can be used with any of the docking stations/devices described ordepicted in this disclosure (e.g., those shown in FIGS. 2A-36, 42-60J,and), which can be modified as appropriate. The docking deploymentassemblies/systems 7000 (e.g., docking station deployment assembly,docking station deployment system, docking device deployment assembly,etc.) can include a catheter 2200 defining a lumen or delivery passage2202 with an inner surface 2203 and having a distal opening 2206(optionally, a proximal opening 2204 as well), a docking station frame350 capable of being radially compressed and expanded, and a pusher orother retention device 2300 having a distal end 2302 and an outercircumferential surface 2304. The docking deployment assemblies/systemscan also include a handle connected to a proximal end of the catheter2200. The handle can include controls (e.g., knobs, buttons, switches,etc.) for adjusting the assembly/system.

The docking deployment assemblies/systems herein can also (or as analternative to the pusher) include an inner shaft or inner catheter. Theinner shaft/catheter can extends inside the catheter 2200, the dockingstation, and/or the pusher. The inner shaft/catheter can include a nosecone (e.g., a flexible nose cone) to aid in navigation to the targetdeployment site in the body. The inner shaft/catheter can include aguide wire lumen so the docking deployment assembly/system can moreeasily be advanced to the target deployment site. The proximal end ofthe inner shaft/catheter can connect to the handle.

The pusher 2300 can be made of any semi-flexible or flexible materialthat can pass or wind through the catheter 2200 (e.g., when the catheteris positioned in the body and the catheter includes multiple turns indifferent directions along the anatomy) and exert a distal force at thedistal end 2302 of the pusher 2300. The pusher 2300 can be hollow, atube, a coil, and/or can be solid or have a solid cross-section. Thepusher 2300 can have no lumen or have one or more lumens, etc. The frame350 of the docking station 10 can be made from any combination of thematerials disclosed herein. For example, the docking station 10 and itscomponents can be made from a shape memory alloy frame, foam, fabriccoverings, a combination of these, etc. The docking station frame 350can also take any shape, form, or configuration disclosed herein. Thedocking station frame 350, when in a compressed state, and the pusher2300 can be receivable in the lumen/delivery passage 2202 of thecatheter 2200 with the docking station frame 350 near the distal opening2206 of the catheter 2200 and the pusher 2300 proximal of the dockingstation or relatively closer to the proximal end. The distal end 2302 ofthe pusher 2300 can be disposed in abutting contact with or near aproximal end 315 of the docking station frame 350, and a distal end 317of the docking station frame 350 can be disposed within thelumen/delivery passage 2202 of the catheter 2200. At least a portion ofthe pusher 2300 can be sized to have a diameter that is at least aslarge as an inner diameter of the docking station frame 350 when in thecompressed state.

Turning to FIGS. 66A and 66B, the docking station frame 350 and pusher2300 can be disposed in the catheter 2200 such that a distal movement ofthe pusher 2300 (i.e., movement toward the distal opening 2206 of thecatheter 2200) will apply a distal force to the proximal end 315 of thedocking station frame 350, moving the proximal end 315 of the frame 350toward the distal opening 2206 of the catheter 2200. As shown in FIG.66A, as the docking station frame 350 is moved distally through thelumen/delivery passage 2202 (or the catheter 2200 is retractedproximally over the frame 350), the distal end 317 of the frame 350moves distally past the distal opening 2206 of the catheter 2200 and thedistal portion of the frame 350 that is outside the catheter 2200 willbegin to expand radially outwardly. The portion of the frame 350 outsidethe catheter 2200 will expand radially outwardly to a diameter greaterthan that of the catheter 2200 and the portion of the frame 350 withinthe catheter 2200 will remain in the compressed state. As shown in FIG.66B, once the pusher 2300 distally pushes the frame 350 past the distalopening 2206 of the catheter 2200 (or the distal opening 2206 of thecatheter 2200 is proximally retracted beyond the frame 350), the frame350 will be distally past the distal opening 2206 of the catheter 2200and will be fully radially expanded in the desired position.

Optionally, instead of having pusher 2300 be advanced/advanceableaxially through the catheter 2200 to push the docking station/device outof the catheter 2200, the pusher 2300 can be configured as an innershaft or inner catheter (or be replaced by an inner shaft or innercatheter) that remains stationary (e.g., relative to a handle). Theinner shaft/catheter can include, or have attached thereto, a retentiondevice to hold the docking station/device until a desired time (e.g.,until full deployment). Instead of a pusher being advanced through thecatheter 2200, the catheter 2200 (e.g., a retention sheath, deliverycapsule, outer sheath, etc.) can be retracted to release and deploy thedocking station/device. This type of deployment assembly/system can beotherwise similar to those discussed elsewhere herein and includefeatures and/or components of other deployment assembly/systems herein(e.g., those shown in FIGS. 66A-72C).

Referring to FIGS. 12 and 67 through 72C, the pusher or retention device2300 and/or docking station frame 350 of the docking deploymentassembly/system 7000 can be sized, shaped, tethered, or otherwisedesigned such that the positioning of the frame 350 is maintained orotherwise controlled while deploying the frame 350 until the frame 350is fully released from the catheter 2200. In one embodiment, the frame350 is retained by or otherwise connected to the catheter 2200, thepusher 2300, inner shaft/catheter, and/or a retention device even afterthe frame 350 has completely radially expanded. The frame 350 can thenbe released from the catheter 2200, pusher 2300, inner shaft/catheter,and/or a retention device once the docking station frame 350 hascompletely radially expanded. The position of the frame 350 can bemaintained in various ways.

Turning back to FIG. 12 and to FIG. 68A, the docking station frame 350can include at least one leg or extension 319 or multiplelegs/extensions 319. The legs/extensions 319 can be proximallegs/extensions that extend from a proximal end of the frame 350. Eachproximal leg/extension 319 can be a singular rod which extendsproximally (e.g., toward the pusher 2300 or retention device when theframe 350 is disposed in the catheter 2200) beyond other parts (e.g.,beyond all other parts) of the docking station frame 350. In oneembodiment, multiple proximal legs/extensions 319 are evenly spacedaround the circumference of the frame 350 and extend proximally (e.g.,longitudinally, axially, downward) from the proximal most struts 1200.Each proximal leg/extension 319 can include an end shape or foot 321 atan end (e.g., the proximal end) of the leg/extension 319. Each proximalshape/foot 321 can extend circumferentially, radially inwardly, and/orradially outwardly farther than the proximal leg/extension 319. In oneembodiment, the proximal shape/foot 321 is substantially spherical orotherwise bulbous. However, it will be appreciated that the end shapesor feet 321 can be any shape or size receivable within a correspondingtab or slot in the pusher 2300 or other retention device, as describedbelow. For example, the end shapes/feet 321 can be rectangular,elongated, pyramidal, triangular, slotted, grooved, hollow, ring-like,or any other design known in the art.

While the proximal legs/extensions 319 have been described as being apart of the frame 350 of FIG. 12, it will be appreciated that theproximal legs/extensions 319 can be incorporated into any of the dockingstation frames 350 disclosed herein. For example, proximallegs/extensions can be included at the proximal end of the dockingstation frames 350 of FIG. 25 or 26, or any other frame 350 describedherein.

Turning to FIG. 67, an exemplary distal end 2302 of a pusher 2300 orother retention device (e.g., if no pusher is used) is depicted. Theillustrated pusher 2300 (or retention device) includes a plurality ofslots or tabs 2306 in the outer circumferential surface 2304 of thepusher 2300 (or retention device) and disposed around the distal end2302 of the pusher 2300 (or retention device). Each of the slots 2306can be sized, shaped, or otherwise designed to retain a proximalleg/extension 319 and/or end shape/foot 321 of the frame 350 when theframe 350 and pusher 2300 (or retention device) are disposed within thecatheter 2200. In one embodiment, the number, size, and shape of theslots 2306 corresponds to the number, size, and shape of the proximallegs/extensions 319 and/or end shapes/feet 321 of the docking stationframe 350.

Before deployment of the docking station and frame 350, the dockingstation and frame 350 can be inserted into the catheter 2200 with theends/feet 321 and proximal legs/extensions 319 of the docking station orframe 350 being disposed within the slots 2306 of the pusher 2300 orretention device. In one embodiment, the outer circumferential surface2304 of the pusher 2300 or other retention device, the slots 2306, theproximal legs/extensions 319, and the ends/feet 321 are sized such thatthe proximal ends/feet 321 can be retained within the slots 2306 andbetween the pusher 2300 or other retention device and the inner surface2203 of the catheter 2200 when disposed within the catheter 2200. Insome embodiments, pusher 2300 moves or can move distally out of thecatheter 2200 to push the docking station and its frame 350 distally outof the distal opening 2206. In some embodiments, the catheter 2200(e.g., an outer sheath, sleeve, delivery capsule, etc.) is retracted touncover and release the docking station and its frame 350. For aself-expandable frame, as the docking station or frame 350 is uncovered(e.g., by retracting the catheter 2200 and/or pushing it out of thecatheter 2200), the uncovered portions begin to radially expand.

While the slots 2306 are still within the catheter 2200, the position ofthe frame 350 can be maintained or otherwise controlled, as the proximalfeet 321 will still be retained within the catheter 2200. As such, theframe 350 can substantially expand radially outward while a portion ofthe frame 350 can be maintained or otherwise controlled by the catheter2200, pusher 2300, inner shaft/catheter, and/or retention device. Once asubstantial portion of the slots 2306 have moved distally past thedistal opening 2206 of the catheter 2200, the proximal feet 321 can bereleased from the slots 2306 and the positioning of the frame 350 can beset. Self-expansion of the frame 350 can cause the extensions/legs andends/feet to move radially out of the slots when uncovered.

Optionally, the pusher or other retention device can comprise or beconfigured as a lock and release connector similar to that shown anddescribed in PCT Patent App. No. PCT/US2018/040337, filed Jun. 29, 2018,and U.S. Provisional Patent App. No. 62/527,577, filed Jun. 30, 2017,each of which is incorporated by reference in their entirety herein. Thelock and release connector can comprise a body and a door (or,optionally, multiple doors) engaged with the body, wherein the at leastone door (or each of the multiple doors) is moveable from a firstposition to a second position. The door can be integral with the body orconnected to the body. The door can be constructed in a variety of waysand can comprise a variety of different materials. The lock and releaseconnector can further comprise one fastener or multiple fastenersconnecting at least one portion or end of the door to the body.

The docking station/device and frame 350 can have one or moreextensions/legs and can be disposed in the catheter 2200. If an innershaft/catheter is used, the lock and release connector can be connectedto the inner shaft/catheter. Slots 2306 can be formed between the bodyand the door. An extension/leg of the docking station and frame can beinterposed between the body and the door (e.g., in a slot). Optionally,the lock and release connector can further comprise a second door, and asecond extension/leg of the docking station and frame can be interposedbetween the body and the second door. The body can be hingedly connectedto the door(s).

The catheter 2200 with the docking station therein can be positioned ata target delivery site. The catheter 2200 can be retracted or the framepushed out of the catheter 2200 until a distal end of the dockingstation or frame is positioned outside the catheter 2200. The catheter2200 can further be displaced (e.g., withdrawn, etc.) with respect to orrelative to the docking station and the lock and release connector untilthe door(s) open and release the extension(s) from between the body andthe door. The door(s) can be biased (e.g., include a spring, etc.) tocause the door(s) to open when the catheter 2200 no longer covers thedoor to help release the extension.

Referring to FIG. 68A through FIG. 72C, three exemplary dockingdeployment assemblies/systems 7000 are depicted which permit a user tomaintain or otherwise control the position of frame 350 once frame 350has been fully radially expanded outside the catheter 2200.

Turning to FIG. 68A through FIG. 70, an exemplary docking stationdeployment assembly 7000 is shown. The frame 350 includes at least oneelongated leg/extension 323 disposed at the proximal end of the frame350 and attached or otherwise secured to a proximal strut 1200. Eachelongated leg/extension 323 can include a foot/end shape 325 at theproximal end of the elongated leg/extension 323. Each end/foot 325 canextend circumferentially, radially inwardly, and/or radially outwardlyfarther than the elongated leg/extension 323. In one embodiment, theend/foot 325 is substantially spherical or otherwise bulbous. However,the end/foot 325 can be any shape or size receivable within acorresponding tab or slot in the pusher 2300 or other retention device.For example, the end/foot 325 can be rectangular, elongated, slotted,grooved, hollow, ring-shaped, or any other design known in the art. Theframe 350 can also include proximal legs/extensions 319 and endshapes/feet 321 as previously described. In one embodiment, theelongated leg/extension 323 is included on the frame 350 in place of oneof the proximal legs/extensions 319 and the elongated leg/extension 323extends longitudinally farther away from the remainder of the frame 350than the proximal legs/extensions 319. While the illustrated embodimentsdepict the frame 350 as having only one elongated leg/extension 323,more than one elongated leg/extension 323 can be included.

The at least one elongated leg/extension 323 of the frame 350 can take avariety of forms. As shown in FIGS. 69A and 69B, the at least oneelongated leg/extension 323 of the frame 350 can be flexible, like aflexible rod (FIG. 69A), or rigid, like a rigid rod (FIG. 69B). Theinclusion of a flexible (e.g., spring-like, coiled, thinned, slotted,etc.) elongated leg/extension 323 can permit the frame 350 to extendsmoothly out of the catheter 2200 as the frame 350 radially expands asit is distally moved out of the catheter 2200. For example, after theproximal legs/extensions 319 have been released from the slots 2306 butwhile the end/foot 325 is still retained in the elongated recess or slot2308 within the catheter 2200, the flexible (e.g., spring-like, etc.)elongated leg/extension 323 can flex, expand, or otherwise adjust tocorrespond to (or such that a portion thereof corresponds to) the radialexpansion of the frame 350. The inclusion of a rigid (e.g., rod-like,etc.) elongated leg/extension 323 can permit the frame 350 to bepositioned or otherwise moved once the frame radially expands as it isdistally moved out of the catheter. For example, after the proximallegs/extensions 319 have been released from the slots 2306 but while theend/foot 325 is still retained in the slot 2308, the rigid elongatedleg/extension 323 can securely retain the frame 350 to the pusher 2300,retention device, inner shaft/catheter, and/or catheter 2200 such thatthe frame 350 can more easily be positioned or otherwise moved afterexpansion. However, it will be appreciated that the elongatedleg/extension 323 can take other forms. For example, the elongatedleg/extension 323 can be curved, twisted, bent, or otherwise shapedaccording to the desired deployment and/or control of the frame 350 outof the catheter 2200.

As shown in FIG. 70, the distal end 2302 of the pusher 2300 or otherretention device can include at least one elongated slot 2308 in theouter circumferential surface 2304 of the pusher 2300 or other retentiondevice. The at least one elongated slot 2308 can be sized and shaped tocorrespond to the size and shape of the elongated leg/extension 323 (ora portion thereof) and/or end/foot 325 of the frame 350. The pusher 2300or other retention device can optionally include one or more additionalslots 2306 (e.g., in the outer circumferential surface 2304 of thepusher 2300 or other retention device, between a body anddoor(s)/latch(es), etc.). The optional one or more elongated slots 2308and one or more shorter slots 2306 can extend from the distal end 2302of the pusher 2300 or other retention device toward the proximal end ofthe pusher 2300 or other retention device (e.g., axially or parallel toa longitudinal axis). In one embodiment, the one or more slots 2308extend proximally farther from the distal end 2302 of the pusher 2300 orother retention device than the one or more optional slots 2306.

Before deployment of the frame 350, the frame 350 (and, optionally, apusher) can be inserted into the catheter 2200 with the proximalends/feet 321 and proximal legs/extensions 319 of the frame 350 beingdirected proximally. The ends/feet 321 and/or proximal legs/extensions319 (e.g., a portion thereof) of the frame 350 can be disposed withinthe slots 2306 of the pusher or retention device 2300. In oneembodiment, the outer circumferential surface 2304 of the pusher orretention device 2300, the slots 2306, the slots 2308, the proximallegs/extensions 319, the proximal ends/feet 321, the elongatedlegs/extensions 323, and the ends/feet 325 are sized such that theends/feet 321 can be retained within the slots 2306 (e.g., between thepusher or retention device 2300 and the inner surface 2203 of thecatheter 2200 or between the body of the retention device and adoor/latch) and the one or more ends/feet 325 of the one or moreelongated legs/extensions 323 can be retained within the slots 2308(e.g., between the pusher or retention device 2300 and the inner surface2203 of the catheter 2200 or between the body of the retention deviceand a door/latch) when the pusher or retention device 2300 and one ormore ends/feet are disposed within the catheter 2200.

As the docking station/device moves out of the catheter 2200, the frame350 exits the distal opening 2206 and the frame 350 begins to expand.While at least one extension/leg (e.g., a portion thereof) and/orend/foot is still retained within the catheter 2200 (e.g., in aretention device), the position of the frame 350 can be maintained orotherwise controlled. As such, the frame 350 (e.g., progressively thedistal end, then other distal portions of the frame, then the middle ofthe frame, then proximal portions, and substantially all of the frame)can be substantially expand radially outward while a portion of theframe 350 (e.g., one or more extensions/legs, a portion(s) thereof,and/or one or more feet/end(s) thereof) is maintained or otherwisecontrolled by the catheter 2200 and/or pusher or retention device 2300.

In one embodiment, where the retention device (e.g., pusher) includes atleast one elongated slot 2308 and at least one shorter slot 2106, afterall or most of the shorter slot(s) 2306 have moved distally past thedistal opening 2206 of the catheter 2200 (e.g., is uncovered byretraction the catheter or advancing a shaft or pusher), one or moreends/feet 321 are released from the slot(s) 2306 and frame 350 is fullyradially expanded (e.g., expanded until in contact with the circulatorysystem). Even after shorter slot(s) 2306 have moved distally past thedistal opening 2206 of the catheter 2200, the at least one end/foot 325of at least one elongated leg/extension can still be retained within theelongated slot 2308 (e.g., all or a portion thereof). As such, the frame350 can completely radially expand and the position of the frame 350 canbe maintained or otherwise controlled by the retention of the elongatedleg/extension 323 and/or end/foot 325 within the catheter 2200. Once allor most of the at least one elongated slot 2308 is uncovered or movesdistally past the distal opening 2206 of the catheter 2200 (e.g., isuncovered by retraction of the catheter or advancing a shaft or pusher),the at least one end/foot 325 can be released from the at least oneelongated slot 2308 and the positioning of the frame 350 can be set. Ifa door/latch is used over any of the slot(s), the door opens to allowthe end/foot thereunder to be released.

In one embodiment, where the retention device (e.g., pusher) includesonly one elongated slot 2308, as the frame 350 moves distally past thedistal opening 2206 of the catheter 2200 (e.g., is uncovered byretraction the catheter or advancing a shaft or pusher), the frame 350is progressively expanded from distal to proximal until fully radiallyexpanded (e.g., expanded until in contact with the circulatory system).Even after all but the end/foot 325 of frame 350 has moved distally pastthe distal opening 2206 of the catheter 2200, the end/foot 325 of theelongated leg/extension can still be retained within the elongated slot2308 (e.g., all or a portion thereof). As such, the frame 350 cancompletely radially expand and the position of the frame 350 can bemaintained or otherwise controlled by the retention of the elongatedleg/extension 323 and/or end/foot 325 within the catheter 2200. Once allor most of the elongated slot 2308 moves distally past the distalopening 2206 of the catheter 2200 (e.g., is uncovered by retraction ofthe catheter or advancing a shaft or pusher), the at least one end/foot325 can be released from the at least one elongated slot 2308 and thepositioning of the frame 350 can be set. If a door/latch is used overthe slot 2308, the door opens to allow the end/foot 325 thereunder to bereleased.

Having only one extension/leg or only one elongated extension/leg 323 ona self-expandable frame acts to help prevent the frame from jumping outof the distal end of the catheter and throwing off the placement. As theproximal end 315 of the frame 350 approaches the distal opening 2206 ofthe catheter, forces can build between the proximal end 315 and distalopening 2206 that can cause the frame to jump forward out of thecatheter. Having multiple legs/extensions at the proximal-most end ofthe frame 350 can make jumping more likely, as the legs/extensions canact against each other and create opposing forces against the distal endof the catheter. By having the proximal end 315 of the frame 350 haveonly one elongated extension/leg 323 (e.g., with or without shorterextensions/legs 319) or only one extension/leg at all (e.g., 319 or323), the frame 350 is allowed to fully expand while retained by onlyone extension/leg, then this one remaining extension/leg can release theframe 350 without causing jumping.

Turning to FIGS. 71A through 71C, an exemplary docking device deploymentassembly 7000 is shown. The docking device deployment assembly 7000 canbe similar to those described above and alternatively or additionallyinclude a suture or retaining line 2700 which can be used to maintainthe position of the frame 350 as the frame 350 is deployed from thecatheter 2200 and fully radially expanded. The inner shaft, retentiondevice, or pusher 2300 is shown as including two suture passages 2310which extend longitudinally through the inner shaft, retention device,or pusher 2300 and which each can receive a portion or an end of thesuture 2700; however, only a single passage can be used. In oneembodiment, the suture 2700 is threaded through one of the suturepassages 2310, around a portion of the frame 350, and back through theother suture passage 2700 such that both ends of the suture 2700 extendthrough the proximal portion of the catheter 2200. The suture 2700 canbe secured around any portion of the frame 350. In one embodiment, thesuture 2700 is looped around one or more struts 1200 or apexes of strutsof the frame 350. In another embodiment, the frame (e.g., apexes of theframe) includes one or more loops, apertures, holes, etc. that thesuture 2700 can be threaded through.

In one embodiment, the pusher 2300 is used to apply a distal force onthe frame 350 to move the frame 350 distally through the distal opening2206 of the catheter 2200 while the suture 2700 applies a proximal forceon the frame 350 to keep the frame 350 in contact with and/or proximatethe pusher 2300 (e.g., by holding the suture or pulling proximally onthe suture). As shown in FIG. 71A, once the pusher 2300 pushes a portionof the frame 350 through the distal opening 2206 of the catheter 2200,the portion of the frame 350 extending beyond the distal opening 2206will begin to expand radially outward, and the proximal force applied bythe suture 2700 will keep the frame 350 (e.g., a proximal end of frame350) in contact with and/or proximate the pusher 2300. In FIG. 71B, oncethe pusher 2300 has pushed the frame 350 completely through the distalopening 2206, the frame 350 can be fully radially expanded and theproximal force applied by the suture 2700 on the frame 350 will maintainthe frame 350 proximate the distal end of the pusher 2300 and/orcatheter 2200. In FIG. 71C, once the frame has been fully radiallyexpanded in the desired position, the suture 2700 can be removed fromthe suture passage(s) 2310 and frame 350 such that the expanded frame350 is deployed in the desired position.

In one embodiment, the suture 2700 applies a proximal force on the frame350 to keep the frame 350 in contact with and/or proximate the innershaft, retention device, or pusher 2300 (e.g., by holding the suture orpulling proximally on the suture) as the catheter 2200 (e.g., outersheath, delivery capsule, sleeve, etc.) is withdrawn. As shown in FIG.71A, once the catheter is retracted such that a portion of the frame 350is exposed, the portion of the frame 350 extending beyond the distalopening 2206 expand radially outward, and the proximal force applied bythe suture 2700 will keep the frame 350 (e.g., a proximal end of frame350) in contact with and/or proximate the inner shaft, retention device,or pusher 2300. As shown in FIG. 71B, once the catheter has beencompletely retracted from over the frame 350, the frame 350 is fullyradially expanded and the proximal force applied by the suture 2700 onthe frame 350 can maintain the frame 350 proximate the distal end of theinner shaft, retention device, or pusher 2300 and/or catheter 2200. Asshown in FIG. 71C, once the frame has been fully radially expanded inthe desired position, the suture 2700 can be removed from the suturepassage(s) 2310 and frame 350 such that the expanded frame 350 isdeployed in the desired position.

While this exemplary docking station deployment assembly 7000 has beendescribed and depicted as including only a suture 2700 (e.g., noextensions/legs are necessary) to maintain the position of the frame 350after the frame 350 has been fully radially expanded, other features canalso be included to maintain the position of the frame 350 after theframe 350 has been fully radially expanded. For example, the frame 350can include proximal legs/extensions 319 and proximal ends/feet 321and/or one or more elongated legs/extensions 323 and one or moreends/feet 325 and the pusher/inner shaft/retention device can includeshorter slots 2306 and/or one or more elongated slots 2308 to maintainthe position of the frame 350 after the frame 350 has been fullyradially expanded, as described above.

Turning to FIGS. 72A through 72C, an exemplary docking stationdeployment assembly 7000 is shown. In the illustrated embodiment, thepusher/inner shaft/retention system 2300 includes a distal portionhaving a first outer circumferential surface 2312 and a proximal portionhaving a second outer circumferential surface 2314. The distal portionand the proximal portion can be integrally formed or the distal portion327 can be a separate component, such as a pin, that is attached to theproximal portion or extends through a lumen of the proximal portion. Inone embodiment, a pin is used as surface 2312 without any largerdiameter proximal portion. The pin and/or distal portion can include alumen through which another portion of the system and/or a guidewire canpass. The distal end 2302 of the distal portion can optionally betapered or otherwise rounded. The first outer circumferential surface2312 of the pusher/retention system 2300 is narrower than or have asmaller diameter than the inside diameter of the frame 350 (or have thesame or a similar diameter) when the frame 350 is in the compressedstate within the catheter 2200 and the second outer circumferentialsurface 2314 of the pusher/retention system 2300 can be wider or have alarger diameter than the inside diameter of the frame 350 when the frame350 is in the compressed state and be narrower or have a smallerdiameter than the inner surface 2203 of the catheter 2200. For example,the frame 350 can be crimped around the outer circumferential surface2312. In one embodiment, the first outer circumferential surface 2312has a large enough diameter to retain a proximal portion of the frame350 in abutting contact with the inner surface 2203 of the catheter2200.

In use, when the pusher/inner shaft/retention system 2300 and frame 350are disposed within the catheter 2200, the distal portion second outercircumferential surface 2314 of the pusher 2300 can abut the proximalend 315 of the frame 350 and the distal portion of the firstcircumferential surface 2312 (e.g., a narrowed portion, a pin, etc.)will be disposed within the inner diameter of the compressed frame 350.Within the catheter 2200, the first circumferential surface 2312 and theinside surface 2203 can trap or constrain a portion of the frame 350that is within the catheter 2200 therebetween. A user can use thepusher/retention system 2300 to apply a distal force on the frame 350 tomove the frame 350 distally through the distal opening 2206 of thecatheter 2200 and/or can retract the catheter 2200 from over the frame350.

In one embodiment, as shown in FIG. 72A, the pusher/innershaft/retention system 2300 can be used to push a portion of the frame350 through the distal opening 2206 of the catheter 2200, and theportion of the frame 350 extending beyond the distal opening 2206 beginsto expand radially outward. In one embodiment, also represented by FIG.72A, the catheter 2200 can be retracted proximally from over the frame350, and the portion of the frame 350 extending beyond the distalopening 2206 expands radially outward. As shown in FIG. 72B, as long asany portion of the frame 350 remains in the catheter 2200, the firstcircumferential surface 2312 of the pusher/inner shaft/retention system2300 and the inside surface 2203 can trap, constrain, or pinch a portion(e.g., at least a proximal portion) of the frame that is in thecatheter. This can help prevent or inhibit the expansion force of theframe 350 from causing the frame 350 to jump and/or exit the catheter2200 before the transition or step between the outer circumferentialsurface 2314 and the inner circumferential surface 2314 reaches the endof the catheter 2200. As such, the frame 350 will have been maintainedin position throughout the deployment of the frame 350 from the catheter2200. As shown in FIG. 72C, when the frame 350 is entirely outside thedistal end of the catheter 2200, the frame 350 can fully radially expandand be deployed in the desired target position. The pusher/innershaft/retention system 2300 can be retracted from the frame 350 andpulled back into or be re-covered by the catheter 2200.

In one embodiment, docking station deployment assembly 7000 includesonly a pusher/inner shaft/retention system 2300 with first and secondcircumferential surfaces to maintain the position of the frame 350 afterthe frame 350 has been fully radially expanded. However, in someembodiments, other features are included to maintain the position of theframe 350 after the frame 350 has been fully radially expanded. Forexample, the frame 350 can include proximal legs/extensions 319 andproximal ends/feet 321 and/or one or more elongated legs/extensions 323and one or more ends/feet 325 and the pusher/retention system 2300 caninclude shorter slots 2306 and or one or more elongated slots 2308,and/or the docking station deployment assembly 7000 can include a suture2700 to maintain the position of the frame 350 after the frame 350 hasbeen fully radially expanded, as described above. Especially where otherretention features (e.g., extensions and slots, doors/latches, sutures,etc.) are used, the distal portion or pin (e.g., surface 2312) need trapthe frame 350 and can have a smaller diameter than the inner surface ofthe frame.

The distal portion or pin with surface 2312 acts to help prevent aself-expandable frame from jumping out of the distal end of the catheterand throwing off the placement. As the proximal end 315 of the frame 350approaches the distal opening 2206 of the catheter, forces can buildbetween the proximal end 315 and distal opening 2206 that can cause theframe to jump forward out of the catheter. These forces make jumpingmore likely, and this is especially true when the proximal end 315 ofthe frame is angled radially inwardly relative to the inner surface ofthe catheter 2200. For example, as more of the frame 350 expands outsidethe catheter, the proximal end 315 remaining in the catheter tends toangle radially inwardly and can build up pressure against the distalopening 2206 and this can flip or spring the frame 350 out of thecatheter as the proximal end tries to expand. By having the distalportion or pin with surface 2312 inside the proximal end 315 of theframe 350, the proximal end 315 is prevented from angling too much outof parallel (e.g., helps the proximal end 315 to remain parallel, nearlyparallel, or more closely parallel) relative to the inner surface of thecatheter 2200 as the frame expands, and this can help prevent or inhibitthe frame 350 from jumping out of the distal end of the catheter 2200.

Referring now to FIGS. 73A through 75B, the frame 350 can include asealing material or cover/covering 8000 disposed on the end 362 of theframe 350 to effectuate a seal between the valve 29 and interior surface416 of the circulatory system when the valve 29 is disposed in the valveseat 18 of the frame 350 and the frame 350 is radially expanded andplaced in the body. The cover 8000 can be a cylinder or substantially acylinder rolled partially backward on itself and can have an end 8002having an inside diameter 8004, an outside diameter 8006, a distalsurface 8008, and a proximal surface 8010. The cover 8000 can comprise asingle sheet of PET (Polyethylene terephthalate), PTFE, ePTFE, anotherpolymer, or other biocompatible material which can provide an effectiveseal. In one embodiment, the cover 8000 can comprise a woven ribbon orfabric, such as a woven ribbon or fabric that comprises PET, PTFE,ePTFE, another polymer, or other biocompatible material.

As shown in FIGS. 74A through 75B, the cover 8000 can be disposed overthe end 362 of the frame 350. The cover 8000 can be secured to the frame350 in a wide variety of different ways. For example, the cover 8000 canbe attached to the frame with sutures, adhered, tied, fused, etc.Turning to FIGS. 74A and 74B, the cover 8000 can be placed onto the end362 of the frame 350. In one embodiment, the end 8002 of the cover 8000abuts the end 362 of the frame 350. The inside diameter 8004 of thecover 8000 is radially inward of and adjacent to the inside diameter 364of the frame 350. The outside diameter 8006 the cover 8000 is radiallyoutward of and adjacent to and adjacent to the outside diameter 366 ofthe frame 350. The proximal surface 8010 of the cover 8000 can extendaround a portion of the retaining portions 314 of the frame 350. In oneembodiment, the outside diameter 8006 of the cover provides a secure fitand/or seal between the frame 350 and the interior surface 416 of thecirculatory system.

Referring to FIGS. 75A and 75B, the cover 8000 can be draped orotherwise disposed entirely around the end 362 of the frame 350. Thecover 8000 can have contours or otherwise undulate between the struts1200 of the frame 350 (FIG. 75A) or the cover 8000 can be flush with theend 362 of the frame 3530 (FIG. 75B). A valve 29 (See e.g. FIG. 63) canbe inserted into the valve seat 18 defined by the inside diameter 364 ofthe frame 350 and the inside diameter 8004 of the cover 8000. In such aconfiguration, the cover 8000 can effectuate a continuous seal betweenthe outside diameter 366 of the frame 350 and the interior surface 416of the circulatory system, around the end 362 of the frame 350, andbetween the inside diameter 364 of the frame 350 and the valve 29. Forexample, when the valve 29 is in the closed position, the valve 29 andthe cover 8000 provide a seal against blood flow.

Referring, for example, to FIGS. 25, 26, and 76, the frame 350 can alsoinclude one or more friction-enhancing features, such as barbs 2518shown in FIG. 76 projecting radially outwardly from the retainingportion 314 of the frame 350. The barbs 2518 can be curved and/orotherwise oriented to prevent the frame 350 from moving from aninstalled position. In one embodiment, the barbs 2518 project radiallyoutwardly from one or more struts 1200. As shown in FIG. 76, when theframe 350 is deployed and expands radially outwardly, the barbs 2518 caninsert into the interior surface 416 of the circulatory system to secureor otherwise maintain the position of the frame 2518. The barbs 2518 canbe oriented such that the frame 350 does not move due to the force ofblood flowing through the heart or other portions of the body (e.g.,angled or curved to point in the direction of blood flow). Any frame 350described or depicted herein can include similar barbs 2518.

As mentioned above, the docking station 10 can be adapted for use at avariety of different positions in the circulatory system. FIGS. 77 and78 illustrate exemplary embodiments where a docking station 10 isconfigured for use in the aorta 900. In FIG. 77, the docking station 10is shown used alone in the aorta. In FIG. 78, the docking station 10 isshown used in conjunction with a graft 902. The docking station 10 usedin the aorta 900 can take a wide variety of different forms. Forexample, the docking station 10 shown in FIGS. 77 and 78 can be any ofthe docking stations 10 disclosed herein.

Referring to FIGS. 77 and 78, the docking station can be placed in theaorta 900 and an extension 950 extends to stabilize the docking station10. In FIG. 77, the docking station 10 is placed inside the annulus ofthe aortic valve AV and the extension 950 extends into the aorta, suchas into the aortic arch. In FIG. 11, the docking station 10 is placedinside the annulus of the aortic valve AV and the extension 950 extendsinto the aorta, such as into the graft 902. However, the extension 950and the graft 902 can take a wide variety of different forms. The graftcan be a surgically installed graft or a graft that is installed througha catheter, without open heart surgery. In one exemplary embodiment, theextension acts as a graft.

The extension 950 can take a wide variety of different forms. In oneexemplary embodiment, the extension 950 is constructed to allow blood tofreely flow through the extension. For example, the extension 950 can bean open cell frame. The extension 950 can comprise spring elements 3700.The extension 950 can comprise wires. In one exemplary embodiment, theextension 950 comprises an open cell frame, spring elements 3700, and/orwires. In the illustrated embodiment, the extension 950 is configured tobend as it extends in the aorta. The extension 950 can be integrallyformed with the docking station 10 or the extension can be madeseparately from the docking station 10 and attached to the dockingstation. Optionally, the extension 950 can be configured as a graft orstent-graft.

Referring to FIGS. 77 and 78, when the docking station 10 is placed inthe aorta, a significant volume of blood flowing through the aorta canbe directed into the valve 29 by a covering/material 21. Thecovering/material 21 can be the same as or similar to othercoverings/materials described herein. The covering/material can be fluidimpermeable or substantially impermeable so that blood cannot passthrough. More or all the docking station frame 350 can be provided withthe covering/material 21, forming a relatively large impermeable orsubstantially impermeable portion.

The foregoing primarily describes embodiments of docking stations thatare self-expanding. But the docking stations shown and described hereincan be modified for delivery of balloon-expandable,mechanically-expandable docking devices, and/or a combination of these,within the scope of the present disclosure. Deliveringballoon-expandable and/or mechanically-expandable docking stations, etc.to an implantation location can also be performed.

A variety of methods of implanting the docking stations and valvesdescribed herein can be used. Steps described herein can be used invarious orders and the various steps can be combined or omitted. As oneexample, a method can include: inserting a docking station deliverycatheter/sheath into vasculature (or a circulatory system) of a patient,the docking station holding a docking station in a compressedconfiguration; navigating the docking station delivery catheter/sheaththrough the vasculature (or circulatory system) to a desiredimplantation location/site; deploying/releasing the docking station suchthat it expands to an expanded configuration and engages an interiorsurface of the circulatory system, vasculature, heart, etc.; inserting avalve delivery catheter (e.g., a THV delivery catheter) into thevasculature (or circulatory system), the valve delivery catheter holdinga transcatheter valve in a compressed configuration; navigating thevalve delivery catheter through the vasculature (or circulatory system)to a desired implantation location/site or to the docking station (e.g.,within the docking station or within a valve seat of the dockingstation); deploying/releasing the valve such that it expands to anexpanded configuration and engages an interior surface of the dockingstation or of the valve seat of the docking station and is securely heldthereby; (expanding can be done by allowing the transcatheter valve toself-expand out of the catheter/sheath, inflating a balloon to manuallyexpand the valve, mechanically expanding the valve, or a combination ofthese).

The deploying/releasing the docking station such that it expands to anexpanded configuration and engages an interior surface of thevasculature, IVC, SVC, aorta, aortic valve, heart, circulatory system,etc. can comprise a partial deployment/release of the docking stationsuch that a portion of the docking station remains in thecatheter/sheath. A step of retrieving or recapturing the docking station(whether fully deployed or partially deployed) can be used and caninvolve retracting the docking station into the sheath/catheter oradvancing the sheath/catheter over the docking station. If retrieved orrecaptured, a step of repositioning the docking station catheter/sheathand the docking station to a second or different/modified location canbe used, then the docking station can be fully deployed/released suchthat it expands to the expanded configuration and engages an interiorsurface of the vasculature, IVC, SVC, aorta, aortic valve, heart,circulatory system, etc.

In view of the many possible embodiments to which the principles of thedisclosed invention may be applied, the illustrated embodiments are onlyexamples of the invention and should not be taken as limiting the scopeof the invention. All combinations or subcombinations offeatures/components of the foregoing exemplary embodiments arecontemplated by this application, e.g., features/components of oneembodiment can be incorporated into other embodiments and the steps ofvarious methods can be combined in different ways and orders. Wetherefore claim as our invention all that comes within the scope andspirit of the following claims.

1. A docking station comprising: an expandable frame configured toconform to an interior shape of blood vessel when expanded inside theblood vessel; at least one sealing portion configured to contact aninterior surface of the blood vessel; and a valve seat, wherein thevalve seat is configured to support an expandable transcatheter valve.2. The docking station of claim 1, wherein the valve seat comprises afirst portion of the expandable frame, and wherein links connect thefirst portion of the expandable frame to a second portion of theexpandable frame, the second portion comprising an annular outer wall.3. The docking station of claim 2, wherein the links are curved in asemi-circular shape.
 4. The docking station of claim 2, wherein theouter wall of the expandable frame comprises a plurality of struts, andwherein a thickness of the links is less than a thickness of the struts.5. The docking station of claim 2, wherein an apex of the links is bentsuch that portions of the links on opposite sides of the apex extendaway from each other at an acute angle.
 6. The docking station of claim2, wherein the links extend from the first portion of the expandableframe to the second portion at an angle with respect to a radialdirection.
 7. The docking station of claim 2, wherein the links aretwisted as they extend from the valve seat to the annular wall.
 8. Thedocking station of claim 1, wherein the valve seat is entirely locatedradially inside and radially overlapping an outer wall of the frame. 9.The docking station of claim 1, wherein the frame has a plurality ofstent segments connected to a plurality of spring elements, and whereinthe spring elements consist of spring wires, compression springs,torsion springs, tension springs, and combinations thereof.
 10. Thedocking station of claim 1, wherein the expandable frame includes afirst leg that extends proximally beyond the remainder of the frame andan elongated second leg that extends proximally further beyond aproximal end of the first leg.
 11. The docking station of claim 1,wherein the elongated second leg is configured to be releasablyconnectable to a retention device such that the retention device caninhibit the docking station from jumping distally out of the catheterafter the rest of the docking station has expanded.
 12. The dockingstation of claim 1, wherein the expandable frame is configured toconform to the interior shape of the blood vessel, when expanded insidethe blood vessel, such that the expandable frame can expand in multiplelocations to conform to multiple bulges of the blood vessel and cancontract in multiple locations to conform to multiple narrowed regionsof the blood vessel.
 13. The docking station of claim 12, wherein theblood vessel is an aorta, and wherein the expandable frame is configuredto conform to an interior shape of the aorta when expanded inside theaorta.
 14. The docking station of claim 1, further comprising a tubulargraft coupled to the expandable frame that extends axially beyond an endof the expandable frame.
 15. The docking station of claim 1, wherein theframe is configured such that, when expanded inside the blood vessel,more than 50% of the docking station contacts an interior surface of theblood vessel and distributes the pressure on the blood vessel from thedocking station over the more than 50% of the docking station.
 16. Anexpandable docking station frame comprising: an annular valve seathaving an end; an annular outer wall comprising struts disposed aroundthe valve seat, links that connect the end of the annular valve seat tothe annular outer wall; and wherein a thickness of the links is lessthan a thickness of the struts.
 17. The expandable docking station frameof claim 16, wherein the links and the struts are integrally formed, andwherein a transition portion transitions from the thickness of the linksto the thickness of the struts.
 18. The expandable docking station frameof claim 16, wherein an apex of the links is bent such that portions ofthe links on opposite sides of the apex extend away from each other atan acute angle.
 19. The expandable docking station frame of claim 16,wherein the links extend from the valve seat to the annular wall at anangle with respect to a radial direction, and wherein the links aretwisted as they extend from the valve seat to the annular outer wall.20. The expandable docking station frame of claim 16, wherein the outerwall is configured to conform to an interior shape of blood vessel, whenexpanded inside the blood vessel, such that the outer wall can expand inmultiple locations to conform to multiple bulges of the blood vessel andcan contract in multiple locations to conform to multiple narrowedregions of the blood vessel.
 21. A docking station comprising: a frameconfigured to transition from a first configuration to a secondconfiguration, wherein, when in the second configuration, at least afirst portion of the frame is curled, and wherein the frame isconfigured such that as the frame transitions from the firstconfiguration to the second configuration, the frame curls back onitself; and a valve seat, wherein the valve seat is configured tosupport an expandable transcatheter valve.
 22. The docking station ofclaim 21, wherein the docking station is configured such that the nativeleaflets can be clamped between the valve seat and another portion ofthe docking station.
 23. The docking station of claim 21, wherein thefirst configuration of the frame is a straightened configuration andwherein, when in the second configuration, the first portion of theframe is curled at least 360 degrees.
 24. A docking station comprising:a frame comprising a retaining portion circumscribing an inflow area anda valve seat configured to support an expandable transcatheter valve,wherein the retaining portion has a first diameter larger than a seconddiameter of the valve seat, and wherein a tapered region transitionsbetween the first diameter and the second diameter in an inflow tooutflow direction, such that the valve seat is positioned entirely toone axial side of the retaining portion without radially overlapping anyof the retaining portion; and at least one sealing portion configured tocontact an interior surface of a circulatory system.
 25. The dockingstation of claim 24, further comprising a toroidal atraumatic outersegment that extends radially outwardly from the valve seat.
 26. Asystem comprising: a first docking station having a first valve seat; asecond docking station having a second valve seat, wherein each of thefirst valve seat and the second valve seat is configured to support anexpandable valve; and a connecting portion connecting the first dockingstation and the second docking station together to form a dual dockingstation; wherein the dual docking station is configured such that thefirst docking station can be implanted in an inferior vena cava of abody and the second docking station can be deployed in a superior venacava of the body, and have a first valve expanded within the first valveseat and a second valve expanded within the second valve seat.